Quality Assurance Specialist

Job overview

Quality Assurance Specialist is a hybrid role based in Burlington, MA, with required onsite presence. The expected salary range is $81,151–$101,959 per year. PharmaEssentia develops biologics for challenging diseases, including hematology and oncology. The specialist manages product quality processes and supports compliant product release, complaint handling, and drug supply-chain security. The work helps maintain quality records, investigate issues, and coordinate with internal and external stakeholders, auditors, and regulators.

What you'll do

• Manage quality-system processes including change control, deviations, investigations, CAPA, and quality risk management
• monitor records and prepare metrics and trend reports
• coordinate product complaint investigations and documentation
• oversee DSCSA serialization and tracing compliance
• support recalls, withdrawals, and FDA notifications
• review distribution batch records for product release
• participate in audits and inspections.

What we're looking for

Skills & competencies

quality assurance specialist

burlington ma

hybrid

biopharmaceuticals

hematology

oncology

quality management system

capa

dscsa compliance

product complaints

batch record review

$81,151–$101,959 per year

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, and vision coverage
• paid time off
• 401(k) with company match
• flexible spending account
• up to $150 monthly cell phone reimbursement
• Employee Assistance Program.

Why this role

Hybrid work model requiring onsite presence; occasional early or evening meetings with global teams.

About the employer

PharmaEssentia U.S.A. is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.