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Quality Assurance Specialist
Ref No.: 15-02800
Location: Canton, Massachusetts
Start Date / End Date: 12/09/2015 to 12/09/2016
Mission

Member of a Quality Assurance group (contract basis) providing quality and compliance support for aspects of process development and commercial manufacturing of drug substance/drug product.

Support internal and external Quality Systems and Operations, such as facility/equipment, materials and production. Assure compliance with current GMPs.

Key duties

Review/Approve of Batch Records (including Client, Engineering and Development runs) and other related documentation.

General documentation review to support other departments as needed (e.g. reports, Forms, solution records, etc.)

Shop floor support as needed (Quality Oversight, logbook review, solve issues real time with operations personnel, etc.)

SOP/reports generation, review and/or approval

Experience as an investigator (preferred but not required)

Scope and dimensions

Incumbents activities have impact on all GxP-related departments for marketed products manufactured within the Canton and Contract facilities.

Work effectively and efficiently in a cross functional team environment

Maintain the QA relationship(s) with other departments to assure complete and accurate exchange of information, resolution of issues, and timely completion of assigned activities.

Prepare, review and approve controlled documents relevant to GxP operations

Skills:Incumbents activities have impact on all GxP-related departments for marketed products manufactured within the Canton and Contract facilities.

Work effectively and efficiently in a cross functional team environment

Maintain the QA relationship(s) with other departments to assure complete and accurate exchange of information, resolution of issues, and timely completion of assigned activities.

Prepare, review and approve controlled documents relevant to GxP operations

Education:Education:

1. Minimum of a B.S. in Biology, Chemistry, Microbiology or related field

Experience:

1. Must have a minimum 3-5 years of relevant experience within Quality or Compliance
2. Must have previous biologics, biotechnology, pharmaceutical or biopharmaceutical experience.
3. Industry experience with aseptic operations preferred
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