Product Quality Assurance Analyst (Third-Party Manufacturing)

Senior PQA Analyst – Pharmaceutical Quality Assurance

Work Arrangement: Primarily onsite

Schedule: Monday–Friday, 8:00 AM–5:00 PM

Job Summary

We are seeking an experienced Senior Product Quality Assurance (PQA) Analyst to support pharmaceutical Third-Party Manufacturing (TPM) operations. This position will oversee quality assurance activities at external manufacturing sites, ensuring that pharmaceutical products and manufacturing processes comply with cGMP regulations, internal quality standards, and applicable regulatory requirements.

The ideal candidate will have strong pharmaceutical manufacturing QA experience, preferably within biologics, and hands-on expertise in batch record review, deviation investigations, CAPA, change control, and quality systems. Experience working with Contract Manufacturing Organizations (CMOs) or external manufacturing partners is highly desirable.

Fluency in both English and Spanish is required.

Key Responsibilities

• Provide day-to-day Quality Assurance support and oversight for third-party pharmaceutical manufacturing operations.
• Review and approve manufacturing directions, executed batch records, and associated production documentation.
• Ensure drug substance and drug product manufacturing activities comply with cGMP regulations, approved procedures, specifications, and quality agreements.
• Review and approve manufacturing, laboratory, and raw material investigations, including product impact assessments and CAPA plans.
• Evaluate and support change controls, supplier change notifications, and manufacturing process changes.
• Monitor manufacturing processes, quality trends, and recurring events to identify potential quality risks.
• Prepare and perform Annual Product Quality Reviews (PQR/APQR) in accordance with regulatory and internal requirements.
• Coordinate with Quality, Regulatory, Technical Operations, Supply Chain, and external manufacturing partners.
• Participate in global quality review boards and support regulatory submission-related activities involving third-party manufacturing sites.
• Develop and implement change management plans, including risk assessments, planning, and implementation activities.

Required Qualifications

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific discipline.
• Approximately 6 years of experience in pharmaceutical manufacturing operations or Quality Assurance.
• Strong knowledge of pharmaceutical cGMP regulations and quality standards.
• Hands-on experience with manufacturing QA, batch record review, deviation investigations, CAPA, and change control.
• Experience working with pharmaceutical quality systems and independently managing quality-related activities.
• Strong analytical skills, attention to detail, and problem-solving abilities.
• Excellent communication and interpersonal skills, with the ability to work across cross-functional and multicultural teams.
• Fluent in both English and Spanish (required).

Preferred Qualifications

• Experience supporting biologics manufacturing, drug substance, or drug product operations.
• Direct experience with Third-Party Manufacturing (TPM), Contract Manufacturing Organizations (CMOs), or external manufacturing sites.
• Experience with SAP and LRMS.
• Familiarity with Exception Reports, supplier change notifications, and quality technical agreements.
• Experience preparing Product Quality Reviews (PQR/APQR), process trending reports, and change management plans.
• Knowledge of regulatory submissions and global quality review processes.

Additional Information

• Must be available to work Monday through Friday, 8:00 AM–5:00 PM.
• Occasional overtime may be required based on business needs.
• No travel is expected.
• Candidates must currently be local to the work location. Relocation at the candidate's expense is not supported.

Pay: $40.00 - $42.00 per hour

Expected hours: 40.0 per week

Benefits:

• Health insurance

Experience:

• Biologic manufacturing process: 6 years (Preferred)
• Knowledge of GMP regulations : 6 years (Preferred)
• Quality systems: 6 years (Preferred)
• Third-Party Manufacturing (TPM): 6 years (Preferred)
• Contract Manufacturing Organizations (CMOs): 6 years (Preferred)

Ability to Commute:

• Barceloneta, PR 00617 (Preferred)

Work Location: In person