Quality Assurance Specialist/Sr. Specialist

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POST DATE 8/27/2016
END DATE 10/23/2016

WAVE Life Sciences Cambridge, MA

Company
WAVE Life Sciences
Job Classification
Full Time
Company Ref #
360364
AJE Ref #
575993158
Location
Cambridge, MA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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WAVE Life Sciences is seeking a Quality Assurance Specialist/Sr. Specialist. The individual will be responsible for providing Quality Assurance (QA) support to Manufacturing, Quality Control., and R&D (where necessary) for clinical and commercial manufacturing and testing. The successful candidate must have experience in biotech or pharmaceutical (sterile Injectibles) cGMP environment.
This is a great position for an individual who would like to be an architect of the core Quality System for a growing company. Taking the key components and drivers from the commercial cGMP Quality model and fusing it with the flexibility and nimbleness needed to adequately control Quality in earlier Phases.

POSITION RESPONSIBILITIES:
May include some or all of the following:
Write, review and approve GMP documentation (SOPs, protocols, technical reports, specifications, etc.).
Review batch records, testing records, logs, and other documentation to ensure compliance and adequate documentation.
Review and approve validation protocols and reports to ensure compliance.
Perform, document, and review investigations (deviations, OOS, etc), risk assessments, and CAPAs
Support disposition of raw materials, drug substance, and drug product
Review stability protocols and reports
Collaborate with Manufacturing to resolve equipment and process issues
Conduct internal audits, track progress, and trend results
Lead/participate in supplier audits