Manufacturing Compliance Specialist

Merck KGaA, Darmstadt, Germany; St. Louis (MO); On-site; USD 50,000 - 80,000; Full time

Job summary

An innovative company is seeking a Manufacturing Compliance Specialist to ensure quality and compliance within operations. This role involves managing quality records, leading deviation investigations, and collaborating with cross-functional teams to uphold GMP principles. You'll be integral in creating and updating operating procedures while supporting label management for production. If you have a strong background in quality management and are passionate about ensuring compliance in a dynamic environment, this is a fantastic opportunity to make a significant impact in a key role.

Qualifications

• 1+ years of experience in a Quality Management System (QMS).
• 2+ years in an ISO or GMP environment.

Responsibilities

• Manage quality records, deviations, and CAPAs for Ewing operations.
• Create and update Operating Procedures and Packaging Batch Records.

Skills

Quality Management System (QMS)

Root Cause Analysis (RCA)

Corrective and Preventive Actions (CAPA)

Attention to Detail

Effective Communication

Time Management

Problem Solving

Education

Bachelor’s Degree in Chemistry

Bachelor’s Degree in Biochemistry

Bachelor’s Degree in Biology

Bachelor’s Degree in Engineering

Tools

SAP

Microsoft Office

Labelview

Loftware

Job description

Work Location: St. Louis, Missouri
Shift:
Department: LS-SC-PMLED Packaging
Recruiter: Guadalupe Barragan

Hiring Manager: Rhett Mayfield
This information is for internals only. Please do not share outside of the organization.

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.

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.