Quality Assurance II Job

QA SPECIALIST is needed for a CONTRACT opportunity with Yoh's client located in VACAVILLE, CA.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Pharmaceutical
- cGMP
- Quality

WHAT YOU'LL BE DOING:

- Provide Quality oversight to multiple support groups across the sight, with a primary focus on discrepancy management manufacturing, facilities and Quality Control initiated records.
- Lead and participate in the design and implementation of department and cross-functional initiatives.
- Provide assistance/oversight to internal and external customers in support of departmental functions
- Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnership
- Serve as a technical subject matter expert in support of department functions
- Train personnel and internal customers on relevant business process
- Represent QA on cross-functional, multi-site and multi-disciplinary teams
- Review and approve controlled documents and change records relating to processes, equipment, facilities, and utilities in the manufacture of product
- Lead/assist with discrepancy investigations as well as interact with interdepartmental contacts ensuring discrepancy identification, definition, assessment, resolution and Quality approval
- Participate in inspection preparation activities and inspections by health authorities
- Assist with manufacturing facility and equipment startup/changeover/tooling activities
- Collaborate with departments to ensure that all review activities are executed efficiently and effectively
- Identify, design and implement process and system improvements
- Provide input into the design and presentation of departmental performance metrics
- Perform any other tasks as requested by management to support quality oversight activities
- Solve a wide range of difficult issues that impact multiple functions following cGMP regulations and standards by applying advanced theory, technical principals and expert judgment.
- Work independently to provide rationale and approval for processing forward, as well as assessment and closure of cGMP deviations.

WHAT YOU NEED TO BRING TO THE TABLE:

- B.A. or B.S. degree (Life Science/Engineering) and at least four years of relevant experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience
- Sound knowledge of GMPs or equivalent regulations
- Ability to interpret Quality standards for implementation
- Ability to make sound decisions about scheduling, allocation of resources and managing priorities
- Ability to communicate clearly and professionally both in writing and verbally
- Flexibility in problem solving and work hours to meet business objectives

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a DayJ2W: SCIENTIFIC

MONJOB

J2WSWSCI

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