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Quality Assurance Specialist

3 months ago

Boston, United States Randstad USA Full time

Quality Assurance Specialist

  • Pay Rate: 50-55 per hour
  • Shift is 6am - 6pm (3/2/2/3/2/2 schedule)
  • Located in Norwood, MA (100% on-site).
  • Quality on the floor so 75% of the time this person will be on the manufacturing floor. This is a very hands on role.
  • This person will be reviewing comments, initiating deviations, and providing overall oversight of the manufacturing floor.


Moderna is seeking a Specialist to support Quality on The Floor (OTF) oversight of manufacturing activities and Facilities at Moderna Inc. This position will be based in our cGMP Manufacturing site in Norwood, MA and will directly support the growing Personalized Medicine Program at the Norwood, MA site. The main responsibility for this position is to provide quality oversight of manufacturing and Facilities, with a focus on quality on the floor overseeing manufacturing operations including real time review of electronic and paper batch records, minor deviations, alarms, CAPAs, training, and other technical documents. Strong decision- making skills and independent thinking will be paramount for candidate success. The individual will work closely with Manufacturing, Quality Control, and Facility teams.


Key Responsibilities of the Position:

• Provide quality on-the-floor support of manufacturing, reviewing documentation, and providing

real-time support of manufacturing issues change overs etc.

• 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.

• Supports, reviews and approves Deviations and change controls

• 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 Moderna’s 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.


Required Background:

• Education: Bachelor’s degree.

• Experience: BS with 3+ years of experience, or a Master’s level degree with at least 1 year

experience in the pharmaceutical/biotech industry.

• Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP

regulations.