Sr. Quality Assurance Specialist 8/24/2016

Confidential Company Tampa, FL

Company
Confidential Company
Job Classification
Full Time
Company Ref #
29268974
AJE Ref #
575973610
Location
Tampa, FL
Job Type
Regular

JOB DESCRIPTION

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SUBJECT: Sr. Quality Assurance Specialist - Pharmaceutical Client

Job Title: Sr. Quality Assurance Specialist - Pharmaceutical Client

Location: Summit, NJ

Duration: Long Project

CORE JOB FUNCTIONS:

* Providing Quality Assurance (QA) support to Manufacturing, Quality Control, Analytical Development and Process Development.

* Primarily work with Manufacturing Associates, Quality Control Analysts, and other QA Specialists in supporting clinical product manufacturing and testing.

* Write and review GMP documentation (SOPs, protocols, technical reports, specifications, etc.)

* Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met

* Review validation protocols and reports to ensure compliance

* Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans

* Support disposition of raw materials, drug substance, and drug product

* Review stability protocols and reports

* Collaborate with Manufacturing to resolve equipment and process issues

KNOWLEDGE/SKILLS/ABILITIES (KSA's):

* MUST have experience in a biotech or pharmaceutical cGMP environment.

* MUST have AS/ BS in a scientific or engineering discipline

* MUST have 3 - 5 years Quality Assurance experience in the pharmaceutical/biotech industry

* Prefer knowledge of technical and quality concepts of the manufacturing and testing of pharmaceutical/biotech products.

* Prefer knowledge of cGMP principles with respect to US, EU, and other relevant regulatory guidance

* Prefer experience in reviewing and approving cGMP related documents (SOPs, protocols, reports, batch records, etc.)

* Prefer proficiency with enterprise systems, i.e., documentation, LMS (learning management systems), deviations, CAPA, etc.

* Prefer experience in participating in deviation investigations, determining root cause, and developing corrective action plans

* Prefer ability to identify technical problems and suggest resolution of the issues

* Prefer experience with cellular therapeutics