Senior QA Specialist - GMP Compliance & Batch Release

Veranova; Harvard (MA); On-site; USD 90,000 - 105,000; Full time

Benefits offered by this job

Health & Wellness

401(k) Plan with match

Tuition Assistance

Mentorship

Job summary

Veranova is seeking a seasoned QA professional to monitor day-to-day QA/QC activities within the Pharmaceutical Materials unit, ensuring compliance with FDA and EU requirements. You will review Master Batch Records, perform batch disposition, and provide documentation guidance to support lot release processes.

The role requires extensive knowledge of GMP, ICH Q7, 21 CFR Part 11, and experience mentoring staff.

Qualifications

• Experience with Quality Assurance oversight and support for all phases of clinical trials.
• Experience with supporting On the Floor Walkthroughs of Manufacturing areas.
• Experience with Active Pharmaceutical Ingredients (APIs) and commercial phase pharmaceuticals.
• Experience working with Clients, direct facing and email communications.

Responsibilities

• Provide QA oversight and support for cGMP, ICH, and ALCOA+ principles on the floor and off the floor.
• Review and ensure completeness and compliance of Master Batch Records and related documentation.
• Perform batch disposition and lot release activities.
• Approve and maintain documentation to support QA/QC procedures and audits.

Skills

QA oversight

FDA regulations knowledge

GMP / ICH Q7 familiarity

Documentation review

Client communications

Training and mentoring staff

Education

BS in scientific discipline

MS in scientific discipline

Job description

Veranova is seeking a seasoned QA professional to monitor day-to-day QA/QC activities within the Pharmaceutical Materials unit, ensuring compliance with FDA and EU requirements. You will review Master Batch Records, perform batch disposition, and provide documentation guidance to support lot release processes.

The role requires extensive knowledge of GMP, ICH Q7, 21 CFR Part 11, and experience mentoring staff.