QA Specialist Job

QA SPECIALIST needed for a CONTRACT HIRE opportunity with Yoh's client located in SAN CARLOS, CA.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Eight (8) years of related pharmaceutical experience.
- Bachelor degree in a scientific discipline is required.
- Experience with batch record review and batch disposition.

WHAT YOU'LL BE DOING:

- Responsible for performing QA batch record review, preparing documentation for bulk drug product and raw material release.
- Provides general quality oversight to operations on the shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise.
- Perform random verifications of routine operational requirements, both on a product/batch level as well as on a process level.
- Responsible for driving product quality improvements by coordinating investigations and corrective actions with all operating units, QA, Site Services, and suppliers to determine root causes and corrective actions to resolve compliance related issues (process failures, product failures, stability failures, and compliance issues, including supplier investigations).
- Responsible for ensuring compliance with Federal (FDA, EPA, OSHA), State and local regulations.
- Drives timely resolution of deviations, disposition of batches and escalates in case of delays within the Process Unit.
- Evaluation and decision of deviations reports in AQWA (TrackWise) compliant with cGMP guidelines and SOPs, while escalating the decision for critical/major deviations to QA management.
- Authoring and revision of QA department SOPs.
- Assigns SOPs for training using the Learning Management System within the QA group.
- Evaluate current operational practices and recommend process improvements to ensure continued compliance to regulatory requirements and industry expectations.
- Actively participates in process improvement teams/initiatives.
- Records, manages and analyzes performance metric data.

WHAT YOU NEED TO BRING TO THE TABLE:

- Minimum of eight (8) years of related pharmaceutical experience.
- Experience with batch record review and batch disposition.
- Experience with Deviation Investigations, Root Cause Analysis and Risk Management Auditing and technical report writing experience.
- Expert knowledge and understanding of GMPs, keeping up to date with current industry issues and changing regulations.
- Very good user knowledge for Microsoft Word and Excel.
- Excellent spoken and written communication skills required.
- Bachelor degree in a scientific discipline is required.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- SAP and TrackWise knowledge a plus.

GET HIRED, APPLY NOW!

RECRUITER: Rachel Wertheimer

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Contact us if you are an individual with a disability and require accommodation in the application process.

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TAX TERM: CON_W2

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