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.
- 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
- 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.