Biopharma QA Associate: GMP & Compliance

Planet Pharma; Norton (MA); On-site; USD 52,000 - 66,000; Full time

Job summary

Planet Pharma is seeking an QA Associate at our Norton, MA site to provide day-to-day QA support across manufacturing, validation, materials, QC, engineering and facilities operations. You will help ensure GMP compliance and inspection readiness by partnering with cross-functional teams.

The role requires a Bachelor's degree in a scientific/engineering discipline and 2–4 years of GMP experience. Familiarity with Veeva/SAP and strong attention to detail are advantageous.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline.
• 2–4 years of GMP experience in Quality, Manufacturing, or QC.
• Knowledge of cGMP regulations (21 CFR Parts 210/211/11, ICH Q7/Q10).
• Strong attention to detail and the ability to communicate effectively across teams.
• Experience with quality systems (e.g., Veeva, SAP) is a plus.

Responsibilities

• Provide raw material support, including review/approval of incoming material documentation and release for GMP use.
• Deliver on-the-floor QA support to manufacturing, including area clearance and changeover operations.
• Review and approve SOPs, master batch records (MBRs), specifications, risk assessments, and quality documents.
• Generate and maintain Quality-related SOPs and controlled forms.
• Review and approve validation documents and protocol executions to confirm compliance with approved procedures and regulatory requirements.
• Review and approve QC laboratory qualification documents, including equipment qualification.
• Perform executed batch record review and approval to ensure accuracy and compliance.
• Review and approve deviations, CAPAs, Change Controls and related investigations in the quality management system.
• Support partner audits and regulatory inspections, including document retrieval and subject matter input.
• Approve work orders in the maintenance system to verify equipment maintenance and calibration compliance.
• Collaborate with internal cross-functional teams at the Norton facility to drive continuous improvement and quality excellence.

Skills

Attention to detail

Cross-functional communication

Quality systems experience

Education

Bachelor’s degree in Science or Engineering

Tools

Veeva

SAP

Job description

Planet Pharma is seeking an QA Associate at our Norton, MA site to provide day-to-day QA support across manufacturing, validation, materials, QC, engineering and facilities operations. You will help ensure GMP compliance and inspection readiness by partnering with cross-functional teams.

The role requires a Bachelor's degree in a scientific/engineering discipline and 2–4 years of GMP experience. Familiarity with Veeva/SAP and strong attention to detail are advantageous.