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