BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for QA Specialists to work for a leading San Diego biotechnology company.
QA Specialist - Temp - Multiple Openings
Perform Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP’s, Safety initiatives, Company policies, FDA and DEA regulations. Document all work performed, ensuring accuracy and thoroughness. Inform management of any deviations from established standards/procedures. Assists in investigations where requested. Performs other duties to support general QA functions as assigned or directed.
Inspect and approve rooms, lines and equipment prior to use by manufacturing. Monitor manufacturing areas for compliance with internal SOPs, cGMPS and FDA/DEA regulations. Collaborate with manufacturing team leads or supervisors in resolving quality issues Document all work activity in appropriate batch records, forms, and logs to ensure accuracy and compliance. Sample in-process items, and finished products. Perform required inspections and testing of in-process items and finished products. Process and distribute samples to different departments. Review records for cGMP compliance for accuracy and thoroughness. Inform management of problems, failures and deviations from established internal and regulatory standards. Help /assist in training personnel. Apply disposition stickers to components and in-process materials. Issue and reconcile labeling. Support other quality systems such as customer complaint investigations, NOE , deviations, CAPA, change control as needed. Performs other duties or special projects as required.
Education / Experience:
Bachelor’s Degree in scientific or technical field with a minimum of two years experience in an FDA regulated environment, preferably pharmaceuticals. Knowledge, cGMPs and FDA regulations. Basic computer skills required. Basic math skills required (i.e., calculating %, addition, subtraction, multiplication, division). Ability to read, write neatly, communicate and follow instructions (verbal and written) in English is required. Familiarity with sampling methodologies (i.e. AQL, ANSI-stds) required. ASQ certification a plus.
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Monster - 2 years ago