Qa Specialist I
The Dako Group
- Barceloneta, PR
- Permanente
- Tiempo completo
Duration: 1 Year Contract
Location: Barceloneta, PR (100% onsite)
Schedule: 1st or 2nd Shift (Must be available for any shift, including OT weekends based on business needs)
Payrate: $25/hr to $28/hrWork EnvironmentTeam environment
Batch Record Review areaOvertime - YesInterview Process - 1 Round (Onsite)Required Skills, Experience, EducationBachelor's Degree in Science (preferably on Biology, Chemistry or Biotechnology) or Engineering.
Knowledge and experience in manufacturing of biotechnology products and GMPs is needed, and in aseptic processing is preferable.
Experience working in highly computerized Operations environments– 1 Year
Experience working in a Biotechnology Manufacturing Plant in areas of quality, or manufacturing – 2 Years
The candidate must be proficient in the English language.General Position Summary/PurposeJob 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 Regulatory Audits requests. Revise procedures as required.
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.
Creation and removal of QA Hold condition in SAP system.
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