QA Specialist I

Job Title : QA Specialist I

Duration : 06+ Months

Location : Barceloneta, PR

Pay Rate : $31.70 / hr $33.20 / hr

Job Summary :

The QA Technical Services Specialist is responsible for QA batch record review and disposition, ensuring that bulk and finished product batch documentation complies with Client policies, regulatory requirements, and current Good Manufacturing Practices (cGMP). The role ensures plant products meet all quality and specification standards. This position requires interaction with Quality Assurance, Production, Engineering, IS, and Administration personnel and includes the investigation of deviations, exceptions, and nonconformance reports.

Primary Responsibilities :

• Audit API and / or finished Drug Product electronic and manual (paper) batch records to ensure GMP, policy, and procedural compliance.
• Evaluate potential discrepancies in batch records and determine the need for corrective actions; approve MES exceptions related to production support.
• Track and trend batch record discrepancies as per procedural requirements; work with other departments to evaluate discrepancies and implement actions to reduce errors.
• Provide timely disposition of manufactured products in SAP based on test results and compliance with Regulatory Agency requirements. Prepare Certificates of Analysis and Compliance.
• Enter and verify batch information into the lot restriction management system.
• Assemble batch record review packages and label per approved retention procedures.
• Prepare reports related to Right the First Time, Release Cycle Time, Regulatory Audit requests, and Product Quality Review. Revise procedures as needed.
• Coordinate and participate in weekly Shop Floor Control meetings to discuss batch record status, discrepancies, and issues impacting batch release.
• Demonstrate accountability and responsibility in EHS performance and compliance.

Qualifications : Required :

Bachelor s Degree in Science (preferably Biology, Chemistry, Biotechnology, or Engineering)

2 years experience in manufacturing of biotechnology products; aseptic processing experience preferred

Knowledge of quality regulations and standards in chemical, biological, or medical devices (e.g., Quality Systems, FDA regulations)

Experience in computerized operations environments (SAP, LIMS, MES) and biotechnology manufacturing

1 year of demonstrated problem-solving, analytical, communication, and interpersonal skills

Excellent oral and written communication skills in both English and Spanish

Top 3 5 Required Skills / Experience :

Bachelor s degree in Science (Biology, Chemistry, Biotechnology, or Engineering)

2 years of experience in biotech manufacturing and quality standards, including aseptic processing

Experience in batch record review and audit process

Familiarity with cross-functional QA, Production, Engineering, IS, and Admin interaction for deviation / investigation management

Nice to Have :

Experience specifically in batch record review

Work Environment & Schedule :

Primarily office-based with occasional visits to production areas

Work Schedule : Monday Friday, 8 : 00 AM 5 : 00 PM (flexible as needed)

Overtime : Required

Remote Work : Not available

Travel : Not required

Toxin Handling : No

Interview Process :

Rounds : 1

Interview Panel : Meraris Torres and 2 Area Coordinators