Biotech QA Specialist — Quality & Compliance Expert

ProQuality Network; Juncos (PR); On-site; USD 80,000 - 120,000; Full time

Job summary

ProQuality Network in Juncos, PR is seeking a highly skilled Quality Assurance Specialist to support our client's QA program within the biotechnology industry. This role emphasizes quality oversight, regulated environments, and collaboration with Supply Chain and Incoming Operations.

You will review MPs, approve validation protocols, lead site audits, and own site Quality Program procedures. Strong leadership, data analysis, and regulatory experience are essential.

Qualifications

• Master's degree with 2+ years related experience, or Bachelor's with 4+ years.
• Associate degree with 8+ years related experience.
• High School diploma with 10+ years related experience.

Responsibilities

• Review and approve Master Production Records (MPs).
• Approve process validation protocols and manufacturing reports.
• Lead site audits and investigations.
• Own and maintain site Quality Program procedures.
• Provide lot disposition and authorize shipments.
• Act as QA designee on CCRB and support NPI teams.

Skills

Quality Oversight

Regulatory Knowledge

Leadership

Data Analysis

Documentation

Education

Master's degree

Bachelor's degree

Associate degree

High School diploma

Tools

Microsoft Office

Job description

ProQuality Network in Juncos, PR is seeking a highly skilled Quality Assurance Specialist to support our client's QA program within the biotechnology industry. This role emphasizes quality oversight, regulated environments, and collaboration with Supply Chain and Incoming Operations.

You will review MPs, approve validation protocols, lead site audits, and own site Quality Program procedures. Strong leadership, data analysis, and regulatory experience are essential.