Senior Quality Systems Specialist

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

Your Role:

MilliporeSigma in Rocklin, CA is seeking a Senior Quality Systems Specialist.  The Senior Quality Systems Specialist supports the site Quality Management System and ensures compliance of the Quality System with regulations relevant to the business, including but not limited to ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP, and the Quality Manual; represents Quality on cross-functional teams to support business needs and may lead quality initiatives driving a positive site Quality culture; prepares Quality System documents and reports as needed for Rocklin site metrics and management review; engages opportunities to work on future and current product and process improvements.

The Senior Quality Systems Specialist will support Quality Systems, with a large emphasis in Validation activities including Design, Process, Equipment, Method, and Computerized Systems Validation.

Responsibilities:

• Maintain cGMP compliance in the laboratory

• Write, revise, and/or review Standard Operating Procedures (SOPs)
• Adhere to SOPs and GMP regulations and policies
• Support internal and external audits as required
• Maintain current training requirement
• Train other staff members as requested
• Recommend provide, or initiate solutions by actively providing suggestions for improvement
• Review and approve quality documentation and records
• Collaborate and coordinate with external stakeholders to identify, escalate, and resolve quality issues
• Identify and rectify process gaps; implement robust solutions 
• Collaborate with internal and external stakeholders providing technical support to achieve a compliant Quality Assurance system
• Serve as Quality key contact support for internal and external customers for various Quality systems
• Evaluate Quality Systems for effective support of business processes and improve as needed to meet site goals while maintaining required compliance to regulatory requirements
• Drive improvement initiatives surrounding key performance indicators aligned to management priorities
• Respond promptly to customer needs; solicit customer feedback to improve service; meet commitment