Senior QA Associate: cGMP & Batch Release Expert

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

Benefits offered by this job

Health & Wellness benefits

Annual incentive bonus program

401(k) Plan with company match

Tuition Assistance for Undergraduate/グ

Job summary

Veranova, a global leader in complex APIs for pharma and biotech, seeks a QA professional to ensure GMP compliance in Manufacturing and QA/QC activities for USA and EU markets. You will monitor established procedures, review master records, perform batch disposition, and authorize controlled documents while guiding QA practices and audits.

The ideal candidate has a BS in a scientific field with 5–7 years in FDA-regulated environments, strong GMP/ICH Q7 and 21 CFR Part 11 knowledge, and

Qualifications

• BS in a scientific discipline or equivalent with 5–7 years in an FDA regulated industry.
• Experience with QA oversight for all phases of clinical trials.
• Experience with GMP, FDA regulations, ICH Q7, 21 CFR Part 11.
• Experience mentoring and training staff members in a Quality department.
• Experience supporting client audits and FDA inspections.

Responsibilities

• Support Manufacturing and Quality Control operations on and off the floor, with QA guidance to ensure compliance with cGMP and ALCOA+ principles.
• Review Master Batch Records and provide guidance for completeness and accuracy to support lot disposition.
• Perform Batch Disposition and Lot Release activities.
• Provide final authorization for new controlled documents like master batch records.
• Ensure on-time disposition and delivery of all materials and finished drug substances.
• Review quality event records and deviations, investigations, CAPAs, and customer complaints.

Skills

Quality Assurance oversight

FDA regulations knowledge

GMP compliance

Mentoring staff

Client communications

On-the-floor walkthroughs

ALCOA+ principles

Documentation and records review

CAPA investigations

Audits and inspections

Education

BS in a scientific discipline

Job description

Veranova, a global leader in complex APIs for pharma and biotech, seeks a QA professional to ensure GMP compliance in Manufacturing and QA/QC activities for USA and EU markets. You will monitor established procedures, review master records, perform batch disposition, and authorize controlled documents while guiding QA practices and audits.

The ideal candidate has a BS in a scientific field with 5–7 years in FDA-regulated environments, strong GMP/ICH Q7 and 21 CFR Part 11 knowledge, and