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Quality Assurance Operation

Source Consulting
Norwood, MA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description
Title: Quality Assurance Operation
Location: Norwood, MA
Client: Moderna
Type : 6+ month contract

The Role:
We are currently looking to fill a Quality Assurance Specialist II position. This position
performs activities supporting dispositioning product and/or raw materials while ensuring
compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Client Standard
Requirement Documents.
In this role, a typical day might include the following:
• Representing Quality Assurance in support of sophisticated Deviations, Change
Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem
resolution
• Participating in cross-functional meetings to achieve standard lead time targets for
disposition of drug substance and drug product
• Providing consultation or advice in alignment with QA policies
• Performing activities associated with disposition of raw materials and product (e.g.
receipt, inspection, document review, shipping, etc.), activities may be on the floor or at a desk
• Reviewing, editing, or approving Client controlled documents, to include certificates of
analysis, manufacturing records, and external partner/contract records
• Participating in investigations associated with raw materials or product
• Performing status labelling of raw materials and product
• Continually evaluating Client processes and procedures with an eye toward continuous
improvement
This role may be for you if you:
• Excel in a quality driven organisation
• Have an understanding of biologics manufacturing operations, quality control laboratory
processes and associated quality systems is preferred
• Possess good written, verbal and interpersonal communication skills and the ability to
effectively and comfortably interact cross functionally
• Can prioritise multiple assignments and changing priorities
• Are able to learn and utilise computerised systems for daily performance of tasks

Source Consulting

Address

Norwood, MA
USA

Industry

Technology

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