Overview
Inspection Analyst LPCS Jobs in Portland, OR at Precision Castparts Corp.
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
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
MilliporeSigma in St. Louis, MO is seeking a Manufacturing Compliance Specialist for the Ewing Facility in St. Louis, MO. This Compliance Specialist will be responsible for supporting the Ewing operations through the management of quality records (deviations and CAPAs), managing the creation and updates of operating procedures, and assisting label issuance/management for production. This role will work collaboratively with QA, QC, Operations, Engineering, Validation, Process Development and Maintenance while adhering to GMP principles.
Shift- Monday-Friday, 6am-2:30pm.
Lead and assist in deviation investigations and corrective action identification and actions (CAPA) with a QMS.
Including RCA investigations related to Equipment, Facility, and Process deviations,
Development of CAPA plans and actions,
Working cross functionally to implement corrective actions with relevant departments.
Lead and manage change controls within a QMS.
Create and update Operating Procedures, Packaging Batch Records, Specifications, and Forms.
Maintain quality systems and cGMP compliance
Assist in the generation of CAPA, Deviation, and change control trend reports.
Support the operations label room
Preparing and conducting label printing jobs as required for operations.
Preparing and conducting label accountabilities.
Utilize SAP as needed to consume material quantities and print labels.
Execute label accountabilities and other label related forms utilizing GMP.
Who You Are:
Minimum Qualifications:
Bachelor’s Degree in Chemistry, Biochemistry, Biology, or other Life Sciences or Engineering discipline.
1+ years working within a QMS.
2+ years experience supporting an ISO or GMP environment.
Preferred Qualifications:
1+ years managing or participating in Deviation Creations, RCA, and CAPA implementation.
Strong computer, document management, and attention to detail skills.
Demonstrated ability to work within a cross-functional team.
Effective oral and written communication skills.
Effective, disciplined, and demonstrated documentation skills.
Good time management/organizational skills.
Strong computer skills including SAP and Microsoft Office.
Strong math skills including metrics and conversions.
Good grasp of RCA and CAPA.
Ability to work well in a team setting.
Excellent problem solving skills.
This position will reside in an office setting. Limited travel may be required for training and auditing purposes.
Understanding of regulatory requirements such as ISO 13485 and 21 CFR Part 820.
Expectation is to become proficient and functional in both Labelview (Custom labels) and Loftware (SAP).
Expectation to update and approve labels for IVD and additional products.
RSREMD
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
Show more
Title: Inspection Analyst LPCS
Company: Precision Castparts Corp.
Location: Portland, OR
