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Primary function will be to support projects relating to the Devens investigation program, continuous improvement projects, and additional projects within the quality space.

May 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 all local and global procedures as it relates to site change control system investigations, CAPA, etc. Ensures supporting documentation and change deliverables meet external regulatory and internal WWQC guidelines and requirements.
Represents QA in cross-functional meetings

Qualifications:

Candidate would preferably have project management experience:

Required knowledge of science generally attained through studies resulting in a B.S. in Science, Engineering, Biochemistry or related discipline
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.