1+ months

QA Specialist

Kelly Services
Barceloneta, PR 00617
The QA Technical Services Specialist is responsible for QA batch record review and disposition assuring that bulk and finished products batch record documentation complies with Abbvie policies, regulatory requirements and current Good Manufacturing Practices. The function ensures the plant products meet specifications and quality requirements. This will require interaction with other Quality Assurance, Production, Engineering, IS and Administration personnel. The batch record review encompasses manufactured batch records, investigation of deviations, exceptions and nonconformance reports.


Audit API and/or finished Drug Product electronic and manual (paper) batch records to assure compliance with applicable GMPs, policies, procedures and guidelines. Evaluate potential discrepancies detected in batch records and determine the need for a corrective action. Approve MES exceptions related to production support. Track/trend batch record discrepancies per procedural requirements and work with other departments to evaluate the discrepancies to establish necessary actions to reduce errors. Give timely disposition to manufactured products in the SAP system based upon result of testing and compliance with Regulatory Agency requirements.

Audit requests and Product Quality Review. Revise procedures as required.

Coordinate and participate in plant weekly meetings for Shop Floor Control to discuss batch record status including discrepancies and/or issues that may impact batch release.

Qualifications :

Bachelors Degree in Science in Sciences

Knowledge and experience in manufacturing of biotechnology products Knowledge of Quality regulations and standards affecting chemical, biological or medical devices (i.e. Quality Systems, FDA regulations, etc.)-

2 years experience

3rd (Third) shift role, but Candidates should be available for any shift and Shift Rotation 7/2

**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** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-08-26 Expires: 2022-10-27

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QA Specialist

Kelly Services
Barceloneta, PR 00617

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