Title: QA Associate I (Devices)

Job Summary

Accountable for following cGMP, SOP, incoming inspection of components, sampling, release components, review documents, inventory control, and update electronic inventory system in support of device manufacturing and back-up support for pharmaceutical manufacturing.

Responsible for timely completion of assigned works and tasks.

CORE VALUES

Integrity

Ability to follow policies/practices and make good morale decisions in everyday life. Demonstrating superior honesty, fairness, and discretion based on a very high ethical and prudent moral character from a personal, organizational, and social perspective. Complying established policies, practices, and internal value system to ensure all actions are in line with the organization’s ethical standards.  Recognizing the impact of unfavorable ethical acts and goes out of the way to ensure behavior is unquestionable to represent the organization well. 

Caring/Collaborative Teamwork

Soliciting and sharing ideas, providing respective input and support. Consistently fostering collaboration and respect among all stakeholders (inside and community) by asking/ensuring that all feedback is heard and addressed within the group channels to help everyone collectively reach their goals.  Demonstrating “role model” behavior utilizing a high level of enthusiasm, commitment, and interpersonal skills to drive goals through collaborative synergies.  Communicating in a clear, friendly, respectful business-standard way to create positive relationships and interaction between both internal/external customers.

Innovation

Quickly learning the background, details, and processes to create quality work on time.  Researching, analyzing, and creating enhancements for area of responsibility that creates demonstrable impact to the goals. Networking with individuals for continual feedback and input to reflect and stretching thinking that creates synergies and enhanced ideas for stronger outcomes.

Continuous Improvement

Continually researching new techniques and development opportunities to enhance current skill sets in the areas of dress, communications, presentation skills, and technical performance.  Providing recommendations on trends related to the area that may be transferable to other areas of the organization on an on-going basis. Willingly putting in extra time and effort in crisis situations; goes the “extra mile” to ensure goal is met.  Getting job done efficiently. 

Accountability/Ownership

Taking ownership of the aligned goals and areas of responsibility to ensure objectives are fully met. Making themselves available to others and follows up, as needed, for mutual goal-attainment.  Setting enhanced objectives for self to continually challenge the organization to rise to new heights. Demonstrating optimal inclusiveness and seeking diverse approaches/input on an on-going basis.

Responsibilities

  • Inspection of incoming components
  • Sampling of components, if necessary
  • Release of components
  • Issuance of inventory cards
  • Check all areas of device manufacturing/ assembly for adherence to applicable regulations
  • Perform in-process test and inspections.
  • Monitor the status of materials/products.
  • Performance check of QA equipment.
  • Review batch records
  • Organize batch record dossiers
  • Must participate and successfully complete all training as required by the company
  • Prioritized the work according to the device manufacturing schedule
  • Perform other duties as assigned by management

Knowledge and Skills

Bachelor’s Degree (minimum) in Technical or Scientific Area (Chemical Engineering, Pharmacy, Chemistry) or high school graduate with 2 years of related work experience.  Read, write and understand English.  Adept in basic mathematical skills. Proficient in Microsoft Word, Excel, and Access.

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.  Ability to write routine reports and correspondence.  Ability to speak effectively before groups of customers or employees of the organization.

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.  Ability to deal with problems involving several concrete variables in standardized situations.

Physical Demands

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to handle or feel; reach with hands and arms and climb or balance. The employee is occasionally required to sit; stoop, kneel, crouch, or crawl and taste or smell. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places and fumes or airborne particles. The noise level in the work environment is usually moderate.

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