Quality Control Specialist

Company: Belcan
Location: Berkeley
Posted on: August 3, 2022

Job Description:

Job DescriptionJob Number: 326714Category: QA /QC Duration: 1 yearDetails: A new Quality Control Specialist position located in Berkeley, CA just opened through Belcan! In this role, you will be responsible for coordinating & executing stability studies, meeting regulatory requirements for commercial biotech products. You will also support Technical Registration Documents and any other regulatory document updates. Your support will be required for internal and external audits, as well as QA/QC related investigations. Maintenance of the QC lab and QC Stability documentation is required.Keywords: #Biotech ; #Pharmaceuticals ; #QualityControl ; #Chemist REQUIREMENT/PREFERENCES:- BS/BA- 2+ years of experience in a cGMP laboratory environment and global regulatory compliance organization - Ability to follow GMP SOPs, perform inventory checks, support audit efforts, dispose of samples, and complete stability testing and closeouts- Ability to maintain lab equipment- Remove appropriate inventory from stability chambers to be submitted for stability testing.- Must be able to compile and enter data into LIMS for stability studies, and conduct physical testing in stability chambers- Must be able to travel up to 25% from Berkeley to Emeryville- Strong communication skills, verbal and written- Strong computer skills- Technical writing skills- Ability to work well with othersPREFERENCES: - Knowledge of LIMS, JMP, and SAP systems preferred- Experience with Reference Material Programs or Stability Programs and data evaluation per ICH Guidance preferredBelcan is a global supplier of engineering, technical recruiting, and IT services to customers in the aerospace, industrial, and government sectors. Belcan engineers better outcomes through adaptive and integrated services-from jet engines, airframe, and avionics to heavy vehicles, chemical processing, and cybersecurity. Belcan takes a partnering approach to provide customer-driven solutions that are flexible, scalable, and cost-effective. Our unique capabilities have led to continuous growth and success for nearly 60 years. We are a team-driven Equal Opportunity Employer committed to workforce diversity.

Keywords: Belcan, Berkeley , Quality Control Specialist, Other , Berkeley, California