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Contract Duration: 12-24 months
Rate: Negotiable
Salary: NA $1.00
Responsibilities:
Excellent employment opportunity for a QA Associate II in the Fremont, CA area. Responsible for executing QA operations required to assess, evaluate, and review operations against cGMPs and to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation Responsible for QA oversight of supplier qualification activities (review/approval of raw material and supplier qualification, management of supplier change notifications) Identifies, classifies and reports deviations, as appropriate and typically works on Minor, less complex deviations. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with cross functional team members to determine root cause and potential preventative/corrective actions and ensures support for the timely closure of investigations Performs independent technical review and approval of documentation to support batch release (e.g. review/approval of QC testing documentation, certificate of analysis (COA), in process testing reports) Experience:
Bachelor's Degree, from an accredited institution, in Biology or Chemistry is preferred (or closely related degree with these core courses as the foundation) plus two (2) to four (4) years of Quality Assurance experience. Experience working in Quality Assurance and/or Quality Control for Pharmaceutical GMP operations Ability to effectively communicate both verbally and in writing to peers, superior interpersonal effectiveness and organizational skills Ability to work effectively on problems of diverse scope, with analysis/evaluation of data Attention to detail, safety, quality and customer requirements Experience working with LIMS, SAP, Trackwise, and MS Office Applications Demonstrated knowledge of relevant regulations and guidances. (i.e. cGMPs, SOPs, Protocols).
Compétences linguistiques
- English
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