Sr. Quality Assurance Specialist 8/24/2016
JOB DESCRIPTIONAPPLY 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
* 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