Overview

Summary of job description:

This PQA II position serves as primary QA resource during manufacturing production, providing real time quality oversight. This position will be required to interact with all departments within the company and to proactively support cGMP compliance.

This position is based in our Framingham location and typically has a 5-day on-site expectation.

Responsibilities

Key responsibilities:

• Ensure quality and regulatory compliance during on-the-floor processing.
• Work alongside manufacturing teams to ensure current and best practices are implemented consistently.
• Perform Quality walkthroughs and inspections on the floor, to maintain inspection readiness environment.
• QA support of drug product aseptic fill activities.
• Support as QA contact to review and approve deviations, CAPAs, and change controls.
• Review and/or approve executed production batch records, logbooks, data, and certificates of analyses.
• Assist batch disposition process.
• Review and approve quality documents from Manufacturing, QC, Facilities & Engineering, Validation and PD, such as: SOPs, batch records, logs, training forms, protocols, plans, summary reports, risk assessments, work orders, etc.
• Assist internal and external audits and inspections.

Other responsibilities:

• Assist Quality Management System activities as needed.
• Participate in continuous improvements projects.
• Other duties, as assigned.

Qualifications

Educational requirements:

• Bachelor’s degree in life science preferred.

Experience and skill requirement:

• 2-4 years of quality and/or manufacturing experience in biotech or pharmaceutical industry, working within a quality system and regulated GMP environment.
• Position requires to be able to demonstrate ability to gown aseptically.
• A level of flexibility is essential to meet varying workloads.
• Proficient in using Microsoft applications.
• Familiarity with Quality Management Software (ie MasterControl, Veeva).
• High level of attention to details and excellent time management.
• A very organized and methodical approach to tasks.

Location: 

• This position is based in our Framinghamlocation and typically has a 5-day on-site expectation.