Lead QA Technical Operations


System One

2020-10-12 20:19:42

Job location Ayer, Massachusetts, United States

Job type: fulltime

Job industry: Other

Job description

Title: Lead QA Technical Operations

Location: Devens, MA

Start date: ASAP

Responsibilities:

  • Provides quality support to Devens Site through quality review and approval of investigations and change controls.
  • Reviews and approves discrepancy reporting, investigations and CAPAs associated with all areas of the manufacturing process including, incoming, manufacturing, facility, and utility systems.
  • Assures consistent, effective use of the site change control system for all change requests. Ensures supporting documentation and change deliverables meet external regulatory and internal WWQC guidelines and requirements.
  • May provide Quality support of technical services programs.
  • Represents QA in cross-functional meetings

Requirements:

  • Knowledge of science generally attained through studies resulting in a B.S. in Science, Engineering, Biochemistry or related discipline or its equivalent is preferred
  • Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
  • Knowledge of US and EU cGMP regulations and guidance.
  • Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, SmartLAB and Syncade desirable.
  • Past experience where one was required to work in a team based environment with a diverse group of people.
  • Excellent writing and oral communication skills are required.

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

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