QA Specialist II Job

QA SPECIALIST II needed for a CONTRACT opportunity with Yoh's client located in HOLLY SPRINGS, NC.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Quality Assurance
- cGMP
- Manufacturing

WHAT YOU'LL BE DOING:

- Support the release of manufactured materials such as intermediates and bulk products
- Support the development and maintenance of quality procedures, and systems related to Quality Assurance oversight
- Provide technical support for the US FCC site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the Quality Manual requirements
- Releases intermediates and bulk products using the SAP system
- Ensures all aspects of USFCC operations comply with the requirements of the Quality manual and meets all relevant cGMP regulatory requirements
- Supports the development of quality systems for QA oversight of manufacturing processes, in-process sampling and control, quality systems and QA compliance
- Supports the development and implementation of standard operating procedures (SOPs) and supplemental documents governing management and usage of each quality system of responsibility
- Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site
- Participates as the QA representative on multi-functional continuous improvement (lean, six sigma, issue resolution, etc.) teams, as applicable
- Hands on field execution and data collection, and assist with analysis and review of data
- Execute quality review and approval of GMP documentation such as batch records
- Perform assigned tasks as needed to support quality operations

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's degree in Science/Engineering discipline preferred or equivalent experience in biotech or pharmaceutical industry
- Three or more (3+) years' experience in Quality Assurance and/or in a GMP regulated environment with the pharmaceutical industry or equivalent

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Sterile product manufacturing knowledge preferred
- Biopharmaceutical experience a plus
- Experience with LIMS a plus

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a DayJ2W:PROF

MONJOBJ2WSEMW

Ref:

SFSF: LS