Now Hiring - Quality Systems Specialist - Complaints & Change Management (Hybrid) in Rocklin, CA

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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 looking to add a Quality Systems Specialist to their team. The 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.

Responsibilities:

• Responsible for managing the complaint process including risk assessment, identification of reportable events, investigation, root cause analysis, correction and corrective action, and customer communication

• Responsible for managing the change control process including coordination in TrackWise and assisting internal customers with change implementation

• Write, revise, and/or review Standard Operating Procedures (SOPs)
• Adhere to SOPs and GMP regulations and policies
• Support internal and external audits as required
• Understand and follow the requirements of the quality system
• Maintain current training requirements
• Train other staff members as requested
• Recommend provide, or initiate solutions by actively providing suggestions for improvement
• Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual
• 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, implementing robust solutions
• Respond promptly to customer needs; solicit customer feedback to improve service; meet commitments
• Meet productivity standards without sacrificing quality and safety
• Adhere to established safety procedures; use equipment and materials properly
• Understand, support, and communicate Company mission, vision, and values

This position may include work on weekends or extended hours.

Who you are:

Minimum Qualifications:

• Bachelor's degree in Chemistry, Biotechnology or other Science field with 2+ years of quality experience with a focus on quality systems management in a drug manufacturing, medical device, or biology company OR
• Associate degree in Chemistry, Biotechnology, or other Science field with 4+ years of quality experience with a focus on quality systems management in a drug manufacturing, medical device, or biology company

Preferred Qualifications:

• Excellent understanding of regulatory and standard requirements applicable to the QMS including but not limited to MDSAP, EN ISO 13485, IVDR, Korean cGMP
• Experience in TrackWise highly preferred
• Demonstrated interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, and coordination with cross-functional team members
• Excellent analytical and problem-solving skills
• Detail-oriented with excellent organizational and time management skills
• Excellent oral and written communication skills including ability to create clear, concise, written reports and summaries
• Self-directed and self-motivated with excellent organizational skills with ability to prioritize and work effectively on multiple tasks with varying requirements and deadlines
• Office Suite (Word, Excel, PowerPoint)
• Ability to exhibit objectivity and openness to others' views; give and welcome feedback; support others' efforts to succeed
• Ability to work independently and demonstrate sound and accurate judgment
• Ability to adapt to changing priorities and manage multiple projects with professional resiliency

Pay Range for this position - $49,500 - $148,900

Our ranges incorporate all levels and career types available within this specific role, and are derived from relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

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