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Quality Systems Specialist
2 months ago
Join our team at a leading Pharmaceutical/Medical Device Manufacturing Client in Rocklin CA We are seeking a hardworking and motivated Quality Systems Specialist. Don’t wait—apply today
What's in it for you?
- Role: Quality Systems Specialist
- 100% On-Site @ Rocklin CA
- 12 Month Contract role
- Pay: $28-$30/hr.
- Full time
Job Summary:
- The Associate Quality Systems Specialist will be part of the Quality team and responsible for providing quality support for the site quality management system.
- This position 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.
- This position is multi-disciplinary with opportunities to work on future products and current product and process improvements.
- The position may represent Quality on cross-functional teams to support business needs driving a positive site quality culture.
- The position prepares Quality System documents and reports as needed for Rocklin site metrics and management review.
- Ensure submitted documents comply with company procedures, regulatory requirements, and the quality manual.
- Review and audit Device History Files (DHFs) and technical files, including stability reports, risk management plans, product composition, performance evaluation, and safety reports.
- Assess data and records for proper documentation and record-keeping practices.
- Coordinate file uploads to EDMS; act as technical approver for quality documents.
- Write, revise, and review Standard Operating Procedures (SOPs).
- Support internal/external audits and maintain knowledge of SOPs and policies.
- Provide training, follow quality system requirements, and ensure compliance with regulatory standards (cGMP, ISO 13485, IVDD/IVDR).
- Collaborate with stakeholders to address quality issues and offer improvement suggestions.
- Work weekends or extended hours as needed; perform other duties as required.
Requirements:
- Preferred: Bachelor’s degree in any life science, GMP, Pharma industry experience
- At least 1 year of experience.
Why should you choose Experis?
- Medical, Dental, Vision, 401k
- Weekly pay with direct deposit
- Consultant Care support
- Free Training to upgrade your skills.
- Dedicated Career Partner to help you achieve your career goals.
We are looking for the candidates who are eligible to work with any employers without sponsorship.
Are you Interested?
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If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you
About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.
