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Quality Compliance Specialist

Location : Ramsey NJ US 07446
Job Type : Direct
Reference Code : 20089-AB1
Compensation : 90000.00 - 95000.00 USD/YEAR
Start Date : 01/08/2021
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Biology or Chemistry
Travel : No
Relocation : No
Job Industry : Pharmaceutical

Job Description :


  • Quality Compliance Specialist responsible for QA Compliance activities supporting company Quality Systems and client procedures.

  • Activities include documentation, running investigations, CAPAs, SOPs, qualification and validation reports, and collecting and analyzing QC data.

  • Supports internal and external audits with Health Authorities and clients.

  • Collaborate with Operations, Facilities, QC, and EH&S to provide guidance through all stages of the investigation / CAPA processes.

  • Generate appropriate CAPAs to increase compliance and prevent repeat occurrences of deviations.

  • Conduct trend analysis of compliance related metrics such as deviations and CAPAs.

  • Develop and communicate investigation strategy to key stakeholders.

  • Collect necessary information from appropriate department to close investigation and CAPA. Review and approve investigations and CAPAs.

  • Conduct weekly status update meetings with cross functional departments.

  • Monitor Deviation reporting and CAPA KPIs and provide detailed updates and information to management.

  • Prepares and issues change control as necessary.

  • Ensure adherence to all regulatory agency and company compliance regulations.

  • Performs supplemental investigations and/or participates in project teams.


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 Investigation reports, CAPAs, SOPs, 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 in supporting 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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Please send all inquiries to Allan.Berman@TerkoTech.com




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