At Kelly Science, Engineering, Technology & Telecom (SETT), were passionate about helping you find a job that worksfor you. How about this one?
Were seeking an QA Specialist to work with one of our top global biopharmaceutical clients in the Barceloneta PR area. With us, its all about finding the job thats just right.
Job Responsibilities:
Audit API and/or 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.
Demonstrates accountability and responsibility of EHS performance and compliance.
Knowledge/ Education
Bachelors Degree in Science (preferably on Biology, Chemistry or Biotechnology) or Engineering.
Experience working in a Biotechnology Manufacturing Plant in areas of manufacturing, quality 2 Years
Experience in audit process
• Knowledge in aseptic process
Experience working in highly computerized Operations environments 1 Year
What happens next
Once you apply, youll proceed to the next steps if your skills and experience look like a good fit. But dont worryeven if this position doesnt work out, youre still in our network. That means all our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover whats next in your career is what were all about, so lets get to work.
Kelly PR Offers!
Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information, and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Bi-weekly pay
Among other benefits!
Apply Today!
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