Quality Assurance Specialist
Kelly Scientific Resources - San Diego, CA

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Job Description:
Our client, a growing biotechnology company, is looking
for a Quality Assurance Specialist, to join their team.
Purpose of Job: Under minimum supervision this position
is responsible for Quality Assurance activities as they
relate to the manufacture, in-process, release and
stability testing, and material disposition of drug
substances and drug products manufactured at CMOs and
in-house. Summary Description: Performs and maintains
Quality systems and programs, systems, policies,
processes, procedures and controls as they relate to the
manufacture, analytical testing, and material
disposition of drug substances and drug products
manufactured at CMOs and in-house. Essential Duties and
Responsibilities: Include but are not limited to the
following: Supports equipment, utility, facility
qualification and process validation activities
Independently reviews and releases raw materials
Independently reviews executed manufacturing batch
records, analytical data, and associated documentation,
including any deviations and investigation reports
related to material disposition. Reviews and approves
change control requests to ensure compliance with
Company procedures, cGMP, and other applicable
regulations. Conducts Quality Investigations and tracks
CAPAs. Initiate updates and creation of new SOPs,
procedures as required. Supports external agency and
internal audits as needed Supports regulatory
submissions Aid in implementing process improvements
with respect to Quality Assurance processes.
Qualification Requirements: Education: BS in Biological
Sciences, Chemistry or relevant discipline Experience: 6
+ years of increasing responsibility and applicable QA
experience in a pharmaceutical/biotechnology environment
Broad experience in the pharmaceutical/ biotechnology
industry with Strong technical background in
manufacturing or QC both is positive Formal GMP training
and working knowledge of Quality Systems Excellent and
regulatory requirements Ability to independently
analyze/resolve moderate to complex issues. Demonstrated
initiative and accountability in a fast paced
environment. Strong oral and written communication and
interpersonal skills Proficient with computers and word

processing software PHYSICAL DEMANDS/WORK ENVIRONMENT:
Some evening/weekend may be required to support
manufacturing on occasion.
Job Code : BHJOB3479_581973

Kelly Scientific Resources - 22 months ago - save job - block
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Kelly Services, Inc. (Kelly) is a global temporary staffing provider operating in 36 countries and territories throughout the world. The...