Job Summary

The QA Associate will be responsible for supporting compliance activities for GxP operations. The QA Associate will be responsible for a diverse and challenging set of activities related to setting and maintaining quality standards aligned with FDA cGMP regulations.

 

Work location: Aurora, IL (relocation assistance is not provided)

Responsibilities

Review and approve Deviations, CAPAs, investigations, complaints

Auditing Responsibilities

  • Audit all areas of production for adherence to cGMPs.
  • Perform and participate in internal audits and facility inspections.
  • Support and participate in regulatory audit preparedness and during inspections by regulatory agencies.

Calibrate QA and/or production equipment.

Support QA Associate III in executing cleaning validation, purified water and environmental monitoring programs

Knowledge and Skills

Requires a Bachelor’s degree in any life science, preferably in Chemistry and/or Biology. The various QA Associate II levels require the following experience in a regulated environment in Quality Assurance, Quality Control, Compliance, or Manufacturing with 2 to 4 years’ experience.

The candidate must have training in cGMPs and/or cGxPs and relevant regulatory guidelines. Must be familiar with relevant regulations; formal training and/or advanced courses are preferred. Must have excellent interpersonal skills and the ability to communicate company policies and procedures clearly.

Must have strong organizational and record keeping skills, and the ability to handle multiple projects. Ability to work independently in fast-paced environment with little supervision. Ability to adapt to contact change and work effectively in abstract environment. Candidate must be motivated and detail-oriented. Proficient at mid-level in Microsoft Office applications (Word, Excel, Outlook), data management systems and business related application packages highly desired, plus the ability to learn company used applications.

 

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

This position is for our manufacturing facility in Aurora, IL.

Machine Operator performs a wide variety of activities required to produce high quality pharmaceutical products.

Responsibilities

  •  Manufacturing activities include, but are not limited to: setup, operation, cleaning and troubleshooting of equipment and facilities.
  • Unit operations include: granulation, blending, compression, milling and fluid bed processing.
  • Promotes quality assurance through leadership and example.
  • Provides suggestions for improved efficiency and quality within the manufacturing department.
  • The position requires a high degree of attention to detail and an ability to think critically.
  • Employee needs to have basic understanding of tools and have a basic mechanical aptitude.
  • Understand company goals and objectives and apply them to everyday tasks.
  • Able to work flexible schedule and work extended hours on short notice when necessary.
  • Perform other duties as assigned.
  • Perform other duties as assigned.

Qualifications

  • High school diploma or (GED )with 2-4 years manufacturing experience. Pharmaceutical or Food Industry experience preferred. OR Associate’s/BS degree in Science with 0-3 years of relevant experience. Pharmaceutical or Food Industry experience preferred.
  • Excellent interpersonal and communication skills are essential in this collaborative work environment
  • High degree of professionalism, ethics and integrity
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

Applies engineering principles to design, modify, or develop facilities, testing, machines, equipment, or processes used in the processing, testing, manufacturing, and packaging of pharmaceutical products by performing the following duties.

Responsibilities

  • Analyzes product or equipment specifications and performance requirements to determine designs that can be produced by existing manufacturing or processing facilities and methods.
  • Analyzes engineering proposals, process requirements, and related technical data pertaining to facilities and equipment.
  • Manage all aspects of capital projects, as required, from conception to completion, including budgets, documentation, scheduling, and contractors.
  • Author, manage, and execute all aspects of required Qualification and Computer Validation Documentation as it relates to facility, equipment and/or computer systems.
  • Determines feasibility of designing new plant equipment or modifying existing facilities considering costs, available space, time limitations, company planning, and other technical and economic factors.
  • Provides technical information concerning manufacturing or processing techniques, materials, properties, and process advantages and limitations which affect long range plant and product engineering planning.
  • Compiles and analyzes operational, test, and research data to establish performance standards for newly designed or modified equipment.
  • Studies engineering and technical publications to keep abreast of technical changes and developments in industry.
  • Uses computer assisted engineering and design software and equipment to perform engineering tasks.
  • Provides technical expertise and assistance to the Facilities & Engineering Department for troubleshooting and investigating equipment, facility, and cGMP related issues, including updating documentation, instituting procedures, and authoring/executing qualifications.
  • Perform other duties as assigned.

Qualifications

  • Bachelor’s degree (B. S.) in Engineering (Mechanical preferred).
  • Three plus years related experience in an industrial manufacturing environment.
  • Prior pharmaceutical industry experience is a preferred.

Knowledge and Skills

  • Good written and oral communication skills.
  • To perform this job successfully, an individual should have knowledge of Design software; Project Management software; Spreadsheet software and Word Processing software. Proficient in Auto Cad.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
  • Ability to write reports, business correspondence, and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
  • Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

The Compliance Specialist  will be responsible for managing the vendor qualification program, conducting performing annual product reviews, collecting metrics across the company, and preparing reports for monthly quality council/management review meetings and other technical reports common to the Compliance Department.

Responsibilities

  • Collects metrics across the company for trending of quality performance
  • Performs annual and quarterly trend reports
  • Authors and reviews Annual Product reviews
  • Performs internal audits to ensure compliance against procedures and regulations
  • Performs external audits for suppliers and service providers
  • Manages the vendor qualification program
  • Provides support for execution of special quality projects to implement quality systems, improvements to meet regulatory requirements
  • Provides support during FDA and other regulatory body inspections
  • Updates Standard Operating Procedures (SOP)
  • Supports other departments as directed which may include:
    • Conducts investigative analysis of non-conformance events in the Quality Control laboratory
    • Assigns and communicates corrective and preventive actions (CAPA) to responsible departments based on root cause analysis

Qualifications

  • Bachelors Degree in a lie science such as Chemistry, Microbiology, Biology or related scientific field supplemented with 2-4 years Quality Experience in pharmaceutical industry.
  • Some knowledge of cGMP, FDA and OCHA regulations.
  • Proficiency in Microsoft Office applications (Word, Excel, Outlook, Access) and business related application packages.
  • Experience with Quality Event Management software

 

Knowledge and Skills

  • Strong analytical skills, with an ability to use scientific knowledge and statistical methods to identify potential problems and trends.
  • Ability to organize and write scientific reports
  • Good project management skills
  • Strong computer skills and knowledge of word processing software and spreadsheet software
  • Competent in leading meetings, investigations and team projects
  • Competent in pharmaceutical compliance and regulatory policies
  • Knowledge of pharmaceutical industry guidelines, trends and practices
  • Act with professionalism and treat others with respect and consideration regardless of their status or position
  • Ability to gather information from multiple sources and coordinate and analyze their impact on each other
  • Previous completion of cGMP training

 

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

Compliance Specialist is responsible for administering GMP computer systems used in Quality Control and support computer systems validation projects. Time permitting, also support Compliance department responsibilities including but not limited to vendor qualification program, annual product reviews, internal audits, metrics collection across the company, and preparing for monthly quality council/management review meetings.

 

 

EDUCATION, SKILLS AND/OR EXPERIENCE

Responsibilities

Primary Responsibilities

  • Primary administrator for computer systems used in QC, such as Empower and stand alone instruments
  • Primary administrator for MasterControl company wide document/training/event management software
  • Support Manager Computer Systems Validation in generating/executing computer systems validation documents
  • Prepare change control documentation related to troubleshooting and preventive maintenance activities related to system administration responsibilities
  • Review existing computerized systems for compliance to company procedures, computer validation requirements, data integrity and 21 CFR Part 11 compliance as assigned
  • Write/Review/Update SOP’s related to computer systems in QC and MasterControl
  • Performs internal audits to ensure compliance against procedures and regulations

Support additional Compliance Department responsibilities as time allows:

  • Collects metrics across the company for trending of quality performance
  • Performs annual and quarterly trend reports
  • Authors and reviews Annual Product reviews
  • Performs external audits for suppliers and service providers
  • Manages the vendor qualification program
  • Provides support for execution of special quality projects to implement quality systems improvements to meet regulatory requirements
  • Provides support during FDA and other regulatory body inspections
  • Updates Standard Operating Procedures (SOP)

Supports other department as directed which may include:

  • Assigns and communicates corrective and preventive actions (CAPA) to responsible departments based on root cause analysis

Qualifications

  • Bachelors degree in life science such as Chemistry, Microbiology or related scientific field
  • 2-4 years Quality experience in the pharmaceutical industry
  • Experience with Computer System Validation following GAMP desired
  • Some knowledge of cGMP and FDA regulations
  • Proficient in the use of Microsoft Office applications (Word, Excel, Outlook, Access) and business related application packages
  • Experience with TrackWise, MasterControl or similar Quality Event Management software preferred

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

Job Summary

We are seeking associate analytical scientist to join our Analytical R&D team at our Philadelphia location. This is a laboratory-based position and the candidate will be responsible to support formulation development by performing analytical testing and assisting in analytical method development and validation activities for both ANDA and NDA projects

Responsibilities

Responsibilities

  • Conduct and document chemical and physical testing of finished products, raw materials, API, in-process products, stability samples to support new product formulation development for both ANDA and NDA projects
  • Participate in analytical method development
  • Conduct and document method verification, method transfer, and method validation as per approved method validation protocols, Company SOPs and ICH Guidance
  • Conduct and document in-process and finished product testing for product release and stability as per the approved test methods
  • Effectively communicate with cross functional teams like Formulation Development, Quality Control, Quality Assurance, Compliance and Regulatory Affairs
  • Attend SOP, Safety and scientific training’s to remain current with cGMP regulations, and safety standards
  • Follow relevant Frontida SOP’s and FDA/ICH guidance
  • Other duties as assigned

Qualifications

Qualifications:

  • MS in Chemistry or related major with 0-2 years of experience or a BS degree with 0-3 years’ experience is preferred. Experience with generic drug analysis is desirable.
  • Good understanding of chemical and physical analysis principles, knowledge and experience in chromatography analysis, UV, IR, and dissolution is preferred.
  • Fundamental understanding of GMP, ICH and FDA compliance is preferred.
  • Good written and oral communication skills and interpersonal skills.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

SUMMARY

Performs a wide variety of activities required to produce high quality pharmaceutical products. Schedule for this role is second shift.

 

 

 

Responsibilities

ESSENTIAL FUNCTIONS

  • Manufacturing activities include but are  not limited to, setup, operation, cleaning and troubleshooting of equipment and facilities
  •  Unit operations include granulation, blending, compression milling and fluid bed processing
  • Promotes quality assurance through leadership and example
  • Provides suggestions for improved efficiency and quality within Manufacturing department
  • Understand company goals and objectives and apply them to every day tasks
  • Able to work flexible schedule, and work extended hours on short notice when necessary
  • Perform at line in-process testing such as
    • Loss on drying
    • Particle size distribution
    • Bulk and tapped density
    • Tablet hardness, thickness, and friarbility
  • Perform other duties as assigned

Qualifications

REQUIREMENTS

  • High degree of attention to detail and ability to think critically
  • Basic mechanical aptitude
  • HS Diploma or GED With minimum of 2 years manufacturing. Pharmaceuitical and/or food industry highly preferred
  • Associates or BS plus a minimum of 1 year manufacting experience in Pharmaceutical or food industry

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

This position is for our manufacturing facility in Aurora, IL.

We are seeking a Manager of Manufacturing to join our team! You will oversee the activities of a team of production workers. 

Responsibilities

  • Manages staff and carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, terminating and training employees; planning, assigning, and directing work; appraising performance; counseling employees; addressing complaints and resolving problems.
  • Organize shift schedule to meet production demands. Use and Maintain electronic schedule using Microsoft Project Central or similar tool.
  • Assign operators job responsibilities on daily basis
  • Ensure that necessary materials and supplies are available to facilitate the operators completion of daily job responsibilities.
  • Ensure that operators’ actions are consistently performed with a “safety” minded attitude and are within guidelines determined by cGMP, SOP and Company policy.
  • Support, direct and train operators during the performance of their daily job responsibilities. Support, direct and train materials management personnel during the performance of their daily job responsibilities. Use Electronic Inventory Management and Batch Planning tools as required.
  • Evaluate, review and audit operators performance and work environment for “safety”, cGMP, SOP and Company policy compliance.
  • Work with the maintenance department in order to ensure that the process equipment and supporting machinery are properly maintained. Generate maintenance work tickets as required.
  • Work with the Quality Department to ensure that Quality issues are resolved in a timely manner. Use Electronic Quality Management systems as directed by SOP.
  • Ensure that the BMR (Batch Manufacturing Records) are completed on time and correctly.
  • Must participate and successfully complete all training as required by the company. Create, modify and maintain SOP’s for manufacturing activities.
  • Assist in authoring and reviewing Process Development reports, BMR’s and Protocols.
  • Perform other duties as assigned.

Qualifications

  • B.S. degree in Business, Pharmacy, Chemistry, Engineering with 2+ years’ pharmaceutical manufacturing experience or equivalent combination of education, training and experience.
  • Ability to operate related manufacturing equipment.
  • Proficient in Microsoft Office applications (Word, Excel, Outlook) and business related application packages highly desired, plus the ability to learn company used applications
  • Strong leadership qualities
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe) and business related application packages highly desired, plus the ability to learn company used applications
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

Job Summary

We are seeking analytical Scientists to join our Analytical R&D team at our Philadelphia location. This is a laboratory-based position and the candidate will be responsible to support formulation development by performing method development, validation, writing protocols and reports, conducting chemical and physical testing activities for both ANDA and NDA projects.

 

 

Responsibilities

Responsibilities

  • Develop and evaluate analytical test methods for raw materials and in-process and finished products
  • Write protocols and reports.
  • Conduct and document chemical and physical testing of finished products, raw materials, API, in-process products, stability samples to support new product formulation development for both ANDA and NDA projects
  • Conduct and document method verification and method validation as per approved method validation protocols, Company SOPs, FDA Guidance, and ICH Guidelines
  • Conduct and document in-process and finished product testing for product release and stability as per the approved test methods
  • Effectively communicate with cross functional teams like Formulation Development, Quality Control, Quality Assurance, Compliance and Regulatory Affairs
  • Attend SOP, Safety and scientific training’s to remain current with cGMP regulations, and safety standards
  • Follow relevant Frontida SOP’s and FDA/ICH guidance
  • Other duties as assigned

Qualifications

Qualifications:

  • Ph. D. in Chemistry or related majors with 0-3 years of experience, or a MS degree with 2+ years of experience, or a BS with 5+ years of experience is preferred.
  • Good understanding of chemical and physical analysis principles, experience in method development is preferred.
  • Fundamental understanding of GMP, ICH and FDA compliance is preferred
  • Excellent written and oral communication skills and interpersonal skills

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.