Quality Assurance Specialist - Lexington, MA | Biospace
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Quality Assurance Specialist

WAVE Life Sciences

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Location:
Lexington, MA
Posted Date:
9/15/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
QC, Quality, Quality Control,

Job Description

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

Requirements

Education / Experience:

·       Minimum education required: BS/MS in a scientific or engineering discipline

·       Minimum experience required: Six years experience in Quality Assurance in the pharmaceutical/biotech industry

·       Experience performing and document root cause investigations and risk assessments in a cGMP environment

·       Knowledge of technical and quality concepts of the manufacturing and testing of pharmaceutical/biotech products

·       Knowledge of cGMP principles with respect to US, EU, and other relevant regulatory guidance

·       Proficiency with enterprise systems, i.e., documentation, LIMS (analytical data management), LMS (learning management systems), deviations, CAPA, etc.

·       Ability to identify technical problems and suggest resolution of the issues