Biopharma QA Specialist: Quality & Compliance

PharmaEssentia Corporation; Boston, Northern (MA, KY); Hybrid; USD 81,000 - 102,000; Full time

Benefits offered by this job

Comprehensive medical coverage

Dental and vision coverage

Generous paid time-off

401(k) retirement plan with company 
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Medical & Dependent Care FSAs

Cell phone reimbursement

Employee Assistance Program

Job summary

PharmaEssentia USA seeks a Quality Assurance Specialist based in Burlington, MA, on-site five days a week, to manage the product quality system, deviations, CAPA, and DSCSA compliance. You will coordinate with cross-functional teams and vendors to ensure regulatory alignment and timely product quality releases.

The role requires a life sciences degree and 3+ years in aGxP QA, with strong knowledge of FDA/ICH, DSCSA, and GDP expectations. Competitive benefits are offered.

Qualifications

• Bachelor's degree in life sciences or related field.
• 3+ years QA in pharma/biotech in aGxP environment.
• Knowledge of FDA, ICH, GCP, GMP, GDP guidelines.
• DSCSA and global serialization knowledge.
• Experience with QMS, CAPA, audits, and inspections.
• Strong communication and cross-functional collaboration.
• Ability to adapt to shifting timelines.

Responsibilities

• Manage QMS processes including change control, deviations, investigations, CAPA, and quality risk management.
• Monitor quality records and support timely closure.
• Prepare quality metrics and trend reports for management review.
• Oversee DSCSA serialization compliance and data integrity across the supply chain.
• Coordinate investigations and ensure root cause actions are implemented.
• Review batch records for GDP compliance and support product release.
• Lead quality projects across stakeholders and participate in audits.

Skills

Quality Assurance

FDA regulations

GxP

CAPA

DSCSA

Documentation

Cross-functional

Education

Bachelor's degree in life sciences

Tools

GS1

EPCIS

Job description

PharmaEssentia USA seeks a Quality Assurance Specialist based in Burlington, MA, on-site five days a week, to manage the product quality system, deviations, CAPA, and DSCSA compliance. You will coordinate with cross-functional teams and vendors to ensure regulatory alignment and timely product quality releases.

The role requires a life sciences degree and 3+ years in aGxP QA, with strong knowledge of FDA/ICH, DSCSA, and GDP expectations. Competitive benefits are offered.