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QA Specialist

Location : Ramsey NJ US 07446
Job Type : Direct
Reference Code : 20891-AB1
Compensation : 90000.00 - 110000.00 USD/YEAR
Start Date : 02/04/2022
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Biology or Chemistry
Travel : No
Relocation : No
Job Industry : Pharmaceutical

Job Description :

  • Permanent position for a QA Specialist for Client Services responsible for client specific QA activities including document management, issuance, investigation, CAPA, creating and updating SOPs, Qualification and Validation Reports, etc.

  • Serve as company client services representative at project kick off and weekly meetings.

  • Work with various departments to ensure project related activity is completed on time

  • Create, update, and approve client project documents including SOPs, Batch release templates, label templates, batch records, change controls, etc.

  • Participates in tech transfer activity to ensure adherence to quality system standards.

  • Proactively identifies risk and prepares mitigation strategies associated with project and client work.

  • Ensures all necessary quality documents are closed prior to batch released; responsible for batch released on timely manner according to schedule.

  • Monitor project deliverable quality activities of internal team members.

  • Draft initial Quality agreement and complete necessary revisions based on client and company requirements.

  • Promptly and effectively communicates any successes, challenges, and/or constraints internally and externally with clients as appropriate.

  • Provide quality data to Project Manager to create KPI metrics.

  • Build rapport with clients by resolving their concerns with internal team. Provide appropriate responses to client requests or concerns.

  • Update and maintain accurate client project-related documentation using (i.e., SharePoint).

  • Train Quality Associates on client specific processes to ensure records are complete, accurate and submitted by agreed deadline.

  • Support and participate in internal, regulatory agency and client audit requests.

  • Identifies and supports continuous improvement opportunities throughout various company departments to enhance operations.

Required Qualifications :

  • BS in Biology, Chemistry, or other similar scientific field of study.

  • At least 5 years experience in QA in the pharma/life sciences industry with experience in aseptic manufacturing of biologics.

  • Experience in authoring and approving CAPAs, SOPs, Deviation reports, Investigation reports, and other documentation in a cGMP/cGTP environment.

  • Knowledge of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.

  • Familiar with FDA, ISO, and other regulatory agency guidelines.

  • Understanding of GMP, GDP, and GLP.

  • Experience in both clinical and commercial manufacturing is preferred.

  • Experience participating health authority inspections and/or client audits preferred.

  • Able to work occasional weekends, nights, and/or holidays as necessary.

Contact: Allan Berman

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