Quality Assurance Specialist

About the role

The Quality Assurance Specialist supports the client’s QA program, ensuring product and process compliance across manufacturing operations. Working with minimal supervision, the specialist reviews critical documentation, leads investigations, and collaborates with cross‑functional teams to maintain high quality standards.

Key responsibilities

• Review and approve product manufacturing procedures (MPs) and process validation protocols.
• Approve environmental characterization reports, sanitary utility system releases, and planned incidents.
• Represent QA on New Product Introduction (NPI) teams and act as designee for the QA manager on the local CCRB.
• Lead investigations, site audits, and own site quality program procedures.
• Review risk assessments, support automation, facilities, and environmental programs.
• Review and approve work orders, EMS/BMS alarms, NC investigations, CAPA records, and change controls.
• Provide lot disposition decisions and authorize shipments.

Required profile

• Education: Doctorate, or Masters + 2 years, or Bachelors + 4 years, or Associates + 8 years, or High school/GED + 10 years of directly related experience.
• Strong organizational and project‑management abilities.
• Experience leading cross‑functional teams and interacting with regulatory agencies.
• Excellent written and oral communication skills.

Required skills

• cGMP knowledge.
• MES (Manufacturing Execution System).
• EBR (Electronic Batch Record).
• SAP.
• EDMQ.
• DQMS.
• Trackwise.