Position: Quality Systems Specialist II

Location: Hercules CA USA 94547

Skills: QMS Databases, (EtQ, Trackwise), SAP is a plus

Description:

Our client is seeking a temporary Quality Systems Specialist to assist the Northern California Quality Assurance Operations team in support of manufacturing activities including, supporting product non-conformance investigations and deviations, product quality holds as well as batch record and label review and release.

Responsibilities

• The Quality Systems Specialist will play a key role in supporting various manufacturing activities across several manufacturing locations on the Hercules campus. 
• Activities will include supporting product and process non-conformance and deviation management and product quality holds.
• Administration of investigation and deviation systems for tracking status, follow-up and liaison with applicable department investigation assignee's. 
• Perform activities related to batch record review, product release, assisting with document inquiries, SAP transactions, and posting of C of As.
• Review and compile device history records for accuracy and completeness, and to ensure adherence to in-house specifications and regulatory requirements and document deviations as appropriate. 
• Maintain and archive controlled documentation and completed quality records as needed.

Qualifications

• Associate degree or equivalent in Biology, Chemistry, or related field.
• 2+ years’ experience in a regulated manufacturing industry or equivalent combination of education and experience.
• Understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad with a working knowledge of device/drug/biotech manufacturing processes.
• Detail-oriented and ability to multitask.
• Decision making, time management, organization, communication, leadership, and computer skills.
• Experience with QMS Databases (i.e., EtQ, Trackwise).
• SAP experience is a plus.

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