Quality Assurance Specialist
Kelly Scientific Resources - San Diego, CA

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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.

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Kelly Services, Inc. (Kelly) is a global temporary staffing provider operating in 36 countries and territories throughout the world. The...