QA Specialist, Biopharma — Impactful Quality & Compliance

PharmaEssentia U.S.A.; Burlington (MA); On-site; USD 81,000 - 102,000; Full time

Benefits offered by this job

Medical coverage

Dental and vision coverage

Paid time-off

401(k) retirement plan with company-mq

Job summary

PharmaEssentia USA in Burlington, MA, is seeking a Quality Assurance Specialist to manage the product quality system, review batch records, deviations, CAPA, complaints, recalls, and DSCSA compliance. You will partner with cross-functional teams and HQ QA to ensure timely, compliant product release.

The role requires a Bachelor's degree in life sciences and 3+ years in aGxP QA, with strong knowledge of FDA regulations, ICH guidelines and DSCSA. On-site work five days a week.

Qualifications

• Bachelor's degree in life sciences, pharmacy, biotechnology, chemistry, or related field.
• Three+ years of QA experience in pharmaceutical/biotech with aGxP exposure.
• Knowledge of FDA, ICH, GCP/GMP/GDP expectations.
• Working knowledge of DSCSA and serialization standards.

Responsibilities

• Manage QA processes in the QMS, including deviation, CAPA, change control and risk management.
• Review batch records and support product release.
• Collaborate with cross-functional units and HQ QA for investigations and audits.
• Oversee DSCSA serialization and product tracing compliance.
• Lead quality projects and participate in audits/inspections.

Skills

Quality Assurance

Regulatory knowledge

Cross-functional collaboration

Communication

Attention to detail

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

PharmaEssentia USA in Burlington, MA, is seeking a Quality Assurance Specialist to manage the product quality system, review batch records, deviations, CAPA, complaints, recalls, and DSCSA compliance. You will partner with cross-functional teams and HQ QA to ensure timely, compliant product release.

The role requires a Bachelor's degree in life sciences and 3+ years in aGxP QA, with strong knowledge of FDA regulations, ICH guidelines and DSCSA. On-site work five days a week.