Pharma QA Specialist: Batch Records & Compliance Lead

Allergan; Barceloneta (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

AbbVie is seeking a Specialist, Quality Assurance to review and disposition QA batch records ensuring GMP compliance for bulk and finished products. This role involves collaboration with QA, Production, Engineering, IS and Administration to maintain product quality and regulatory compliance.

Responsibilities include auditing batch records, approving MES exceptions, preparing COA/CoC, and supporting the annual product quality review.

Qualifications

• Bachelor’s Degree in Science preferably in Biology, Chemistry, Biotechnology, Engineering.
• Two (2) years of experience in Quality regulations and standards affecting pharmaceutical, chemical, biological or medical devices (i.e. Quality Systems, FDA regulations, etc.)
• Knowledge and experience in manufacturing of pharmaceutical or biotechnology products is needed.
• At least one (1) year of experience working in highly computerized Operations environments. Knowledge and experience in SAP, LIMS, MES and biotechnology manufacturing process is necessary.
• Incumbent must have excellent problem solving, analytical and communication and interpersonal skills. Excellent oral and written communication skills in English and Spanish are required.
• For biologics, experience in aseptic processing is preferred.
• Availability to work second and third shifts, including weekends and holidays.

Responsibilities

• Audit batch records to assure compliance with GMPs, policies and guidelines.
• Approve MES exceptions related to production support and track discrepancies for corrective actions.
• Coordinate with QA, Production, Engineering, IS and Administration to reduce errors.
• Prepare Certificates of Analysis and Certificates of Compliance for API/finished product.
• Enter and verify batch information into the lot restriction management system; assemble review packages.
• Support the annual product quality review process.

Skills

Quality regulations

Biopharma manufacturing

SAP/LIMS/MES

English & Spanish

Education

Bachelor’s degree in Science

Job description

AbbVie is seeking a Specialist, Quality Assurance to review and disposition QA batch records ensuring GMP compliance for bulk and finished products. This role involves collaboration with QA, Production, Engineering, IS and Administration to maintain product quality and regulatory compliance.

Responsibilities include auditing batch records, approving MES exceptions, preparing COA/CoC, and supporting the annual product quality review.