Quality Assurance Specialist

3 weeks ago

Burlington, United States Randstad Life Sciences US Full time

Specialist, QA

6 Months- likely to go much longer

Burlington, MA

Hourly pay $45.00


Day shift Mon-Fri, 8 hour shift, or Wed-Sat 7-5 (4 10 hr our shifts)


Job Summary

In this role, you will support Quality On The Floor (OTF) oversight of manufacturing activities and Facilities. This position will be based in our cGMP Manufacturing site in Burlington, MA and will directly support the growing Personalized Medicine Program. The main responsibility for this position is to provide quality oversight of manufacturing. Strong decision-making skills and independent thinking will be paramount for candidate success. The individual will work closely with Manufacturing, Quality, and Facility teams

Job Responsibilities

  • Provide quality on-the-floor support of manufacturing, reviewing documentation, and providing real-time support of manufacturing issues change overs
  • Support quality decisions that may impact operations, ensuring appropriate escalation.
  • Identify risks and communicate gaps for quality and GMP process/systems
  • Reviews and approves facility alarms, facility work order requests, and return-to-service documentation
  • Support, reviews and approves Deviations and CAPAs
  • Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations
  • Collaborate with Manufacturing to resolve equipment and process issues
  • Support internal audits.
  • Practice safe work habits and adhere to safety procedures and guidelines
  • Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements
  • Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions
  • Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
  • Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
  • Additional duties as may be assigned from time to time

Education & Qualifications

  • 4 years of experience in the pharmaceutical/biotech industry
  • Demonstrated aptitude or ability to learn to gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards).
  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

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