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Quality Assurance Specialist 9/17/2017

WAVE Life Sciences Lexington, MA

Company
WAVE Life Sciences
Job Classification
Full Time
Company Ref #
374347
Location
Lexington, MA
Experience
Entry Level (0 - 2 years)
Job Type
Regular
AJE Ref #
579548860

JOB DESCRIPTION

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ave Life Sciences is seeking a Quality Assurance 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.

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
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