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QC Analytical Associate

Location : Mahwah NJ US 07430
Job Type : Direct
Reference Code : 20612-AB1
Compensation : 85000.00 - 100000.00 USD/YEAR
Start Date : 06/15/2021
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Science
Travel : No
Relocation : No
Job Industry : Biotechnology

Job Description :

  • Permanent position for a QC Analytical Associate to assist with process check point, stability, and release analytical testing to ensure that quality standards at a Biopharmaceutical manufacturing.

  • Perform accurate execution of all test methods and procedures of cellular products to ensure the safety and efficacy of different cell populations.

  • Perform maintenance, monitoring, and troubleshooting of pertinent equipment.

  • Perform and assists in the training of other Quality Control Analytical Associates.

  • Maintain training records and coordinates records retention with Document Control and Training groups.

  • Test, document, and report results for products or materials following company and/or client procedures following CGMP and/or GTP guidelines.

  • Performs state proficiency testing and/or client proficiency testing under direct supervision as applicable.

  • Participate in managing QC materials and supplies.

  • Perform and assist in equipment and method qualification/validation activities as needed.

  • Perform reagent and media preparation.

  • Lead investigations for out-of-specification, out-of-trend, aberrant, and/or non-conforming test results.

  • Determine root causes and implements intelligent corrective and preventive actions (CAPAs) and monitors CAPA effectiveness.

  • Document training and execution of shipping test samples to contract laboratories for testing.

  • Complete all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).

  • Ensure timely issuance, review, and approval of Certificate of Analysis, alongside timely closures of batch records, deviations, and CAPA.

  • Initiate, assess, approve, track, and trend deviations, Change Controls and CAPAs.

Required Qualifications :

  • BA/BS Science (MS preferred)

  • Minimum 5 years of experience in a biopharmaceutical cGMP Quality Control laboratory setting.

  • Experience in a QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology laboratory in a CGMP/GTP environment.

  • Experience in cell count methodologies and industrial cell therapeutic experience.

  • Experience with gene and Cell therapy.

  • Experience running CBC, NC200 and CANTO machines.

  • Experience with Elisa, Flow, and Cell counts/staining assays.

  • Expertise of compliance requirements in a CGMP setting.

Contact: Allan Berman

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