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1+ months

QA Specialist I

Kelly Services
Barceloneta, PR 00617
Job Description:


Audit finished Drug Product electronic and manual (paper) batch records to assure compliance with applicable GMPs, policies, procedures and guidelines.

Able to approve MES exceptions related to production support worksheets and perform Quality Hold (as required).

Document recommendations for deviations from approved procedures and specifications to assure the capability of meeting product quality requirements prior to release.

Evaluate all deviations documented in batch records and determine the need for a corrective action.

Track/trend batch record discrepancies per procedural requirements and work with other departments (e.g. Manufacturing, Tech Ops, MS&T, MQA) to evaluate the discrepancies to establish necessary actions to reduce errors.

Review of the manufacturing process and related equipment and facilities to assure compliance with procedures, specifications, and policies.

Give timely disposition to materials in the SAP system based upon result of testing and compliance with Regulatory Agency requirements.

Prepare certificate of analysis and certificates of compliance for API and/or finished Drug Product.

Enter required batch information into the lot restriction management system.

Assemble the batch record review package and label per the approved retention procedures.

Prepare reports including Right the First Time, Release Cycle Time and the delay reports.

Generate lot lists for the Product Quality Review.

Coordinate and participate in weekly meetings with Manufacturing and QC Labs personnel to discuss batch record discrepancies and/or issues that may impact batch release.

Act as contact person for projects as required.


Requirements

Bachelors Degree in Science (preferably on Biology, Chemistry or Biotechnology) or Engineering.

Knowledge and experience in manufacturing of biotechnology products and GMPs is needed.

Experience working in a Biotechnology Manufacturing Plant in areas of manufacturing or quality 2 Years


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-04-22 Expires: 2022-06-23

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QA Specialist I

Kelly Services
Barceloneta, PR 00617

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