Mr01-040726 Specialist Qa I

Validation & Engineering Group, Inc

Barceloneta, PR
Permanent
Full-time

6 days ago

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:Specialist QA IDescription:Responsible for auditing and reviewing batch records (electronic and paper) to ensure compliance with GMPs, internal procedures, and regulatory requirements. Supports quality release processes, deviation investigations, and continuous improvement of manufacturing operations.Key Responsibilities:Audit API and/or finished product batch records (electronic and paper) for GMP compliance.
Approve MES exceptions and perform Quality Holds as required.
Document and evaluate deviations and recommend corrective actions.
Track and trend batch discrepancies; collaborate with Manufacturing, Tech Ops, MS&T, and MQA.
Review manufacturing processes, equipment, and facilities for compliance.
Disposition materials in SAP based on testing results and regulatory requirements.
Prepare Certificates of Analysis and Compliance.
Enter batch data into lot restriction systems.
Assemble and manage batch record review packages per retention procedures.
Prepare reports (Right First Time, Release Cycle Time, audit requests).
Generate product quality review lot lists.
Participate in cross-functional meetings regarding batch discrepancies.
Serve as contact person for assigned projects.
Ensure compliance with EHS standards.
Manage QA Hold creation/removal in SAP.Qualifications:Bachelor's Degree in Science (Biology, Chemistry, Biotechnology) or Engineering.
Knowledge of biotechnology manufacturing processes and GMPs (aseptic processing preferred).
Experience in biotechnology manufacturing (quality and/or manufacturing areas) – minimum 2 years.
Proficiency in English (bilingual English/Spanish preferred).
Fully bilingual (English/Spanish) with strong communication skills.
Proficiency in Microsoft Office and Windows environments.
Strong knowledge of cGxP and regulatory compliance.
Experience with:
Design documentation (URS, DS)
IQ, OQ, PQ protocol development and execution
Deviations and investigation reports
SDLC, Risk Assessment, Data Integrity
FAT & SAT processes
Strong technical writing and investigation skills.
Availability for extended hours, weekends, and holidays.At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.Excited to build something meaningful together? We look forward to hearing from you.Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

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