Work Location: St. Louis, Missouri Shift: No Department: LS-SC-PMLABM MFG Biotech & Packaging Recruiter: Erin Wilson
This information is for internals only. Please do not share outside of the organization.
Your Role:
At MilliporeSigma, as the Manufacturing Compliance Specialist at the Cherokee site (3300 S. Second Ave), is focused on ensuring manufacturing and packaging operations are complying with internal procedures. This role completes root cause analysis investigations, change controls and identifies and implements corrective and preventative actions. Job duties include:
Shift: 5:30am - 2:00pm, Monday- Friday
Coordinate documentation and tasks associated with equipment and facilities:
Change management
New Equipment additions
Preventative maintenance and Calibration
Deviations and CAPAs
Work with Manufacturing, Process Development, Maintenance, Engineering, Validation and Quality Assurance to ensure that change controls, deviations, CAPAs are reviewed, approved, and implemented as appropriate
Track and report progress of quality events to management and department impacted
Assist with equipment, facility and process investigations, troubleshooting including root cause analysis
Assist with manufacturing risk assessments
Maintenance of quality systems and cGMP compliance
Ability to understand regulatory requirements such as ISO 13485 and 21 CFR Part 820
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 customer and regulatory audits.
Maintain and review logbooks and other documentation to ensure audit readiness
Always follow safety procedures
Ensure chemical are stored under safe conditions with compatible materials
Don, doff, use, and clean personal protective equipment appropriately
Be familiar with hazards common to assigned work and take action to correct unsafe situations
Participate in required safety activities such as training sessions, meetings, and safety inspections
Develop and assist in the implementation of process improvement ideas
Train other team members on general tasks and safety practices and documentation
Comply with the requirements of ISO 13485 and ISO 9001
Physical Attributes:
Ability to lift/move up to 35bs
Walk, reach above shoulders, stoop, kneel, twist, crouch, crawl, and/or stand and perform repetitive movements for extended periods of time
Ability to navigate 3 flights of stairs multiple times throughout the workday
Who You Are:
Minimum Qualifications:
Bachelor's degree in Chemistry, Biochemistry, Biology, or other Life Science field of study
2+ years of experience supporting/working in an ISO or GMP environment
Preferred Requirements:
1+ year of experience in quality supporting role/field
Understanding of SAP and Track wise
Experience with root cause analysis
RSREMD
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
