What are the responsibilities and job description for the Quality Assurance Associate Specialist position at MilliporeSigma?
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Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role
The Specialist's primary role is to provide support to the Engineering, Facilities and Maintenance Department at the St. Louis sites. This position is responsible for assisting with quality support as it relates to change control, equipment and process deviations, departmental corrective and preventative actions, audit response and routine equipment system maintenance. This position will reside in an office setting. Limited travel may be needed for training and auditing purposes. This position is based in St. Louis at 3050 Spruce St.
Responsibilities:
- Coordinate documentation and tasks associated with equipment and facilities: Change management, New Equipment additions, Preventative maintenance, Calibration, Deviations and CAPAs
- Track and report progress of quality events to management and department impacted
- Assist with equipment, facility and process investigations, trouble-shooting including root cause analysis
- Maintenance of quality systems and applicable ISO standard and regulatory compliance
- Supports equipment commissioning, qualification and validation activities related to GMP manufacturing
- Write, review and/or assist in the development of Manufacturing, Facility or Equipment Operating Procedures
- Assist with documentation and record pull associated teh Facilities, Engineering and Maintenance department during internal and external audits
- Assist in the generation of manufacturing CAPA, deviation and change control trend reports
Who You Are
Minimum Qualifications:
- High School Diploma or GED
- 1 years of experience in a role supporting quality initiatives
OR
- Associate degree in any discipline
- 1 years of experience in a role supporting quality initiatives
Preferred Qualifications:
- 2 years of experience supporting/working in an ISO or GMP environment
- Strong computer and document management skills.
- Demonstrated ability to work within a cross-functional team
- Effective oral and written communication skills
- Effective, disciplined, and demonstrated documentation skills
- Ability to understand regulatory requirements such as ISO 13485 and GxP
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!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html