Quality Control Specialist
Company: Belcan
Location: Berkeley
Posted on: August 3, 2022
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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
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