cGMP Compliance Specialist

Posted 18 Jan 2023

St. Louis, Missouri - United States

Req Id 260100

Work Your Magic with us!

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.


Your Role:

The cGMP Compliance Specialist is responsible for ensuring compliance among our teams, consistent with current Good Manufacturing Practices (cGMPs), and ensuring the accuracy of documentation.  This role will be a department lead in Root Cause Analysis, Change Control, and cGMP document administration.

 

  • Work with Packaging/Warehouse, Manufacturing, Technical Operations, Validation, and Quality Assurance to ensure that change controls, deviations, & CAPAs are reviewed, approved, and implemented as appropriate
  • Coordinate documentation and tasks associated with packaging/warehouse processes:
    • Change management
    • Deviations and CAPAs management
    • Batch documentation, creation, revision, review.
  • Maintenance of quality systems and cGMP compliance
    • Ability to understand regulatory requirements such as ICH Q7
    • Write, review and/or assist in the development of Packaging/Warehouse Operating Procedures
    • Assist with customer and regulatory audits
    • Assist in the generation of manufacturing CAPA, deviation and change control trend reports
  • Drive continuous improvement initiatives
  • Engage in face-to-face discussions with customers and regulatory authorities in support of customer visits, audits, and regulatory inspections
  • Identify potential safety, quality and compliance risks associated with technology transfers / scale-up projects and propose solutions to mitigate risk prior to GMP operations
  • Serve as Team Lead during supervisor absence

 

Who you are:

 

Minimum Qualifications:

  • Bachelor’s degree in Chemistry, Biochemistry, or other Life Science field with 3+ years of experience supporting GMP Operations in a Quality or coordination role AND 2+ years of experience in quality systems administration (Change Control, Deviations, etc.)

            OR

  • Associates degree in Chemistry, Biochemistry, or other Life Science or business degree with 5+ years of experience supporting GMP Operations in a Quality or coordination role AND 4+ years of experience in quality systems administration (Change Control, Deviations, etc.)

 

Preferred Qualifications:

  • 5+ years of experience supporting a GMP Manufacturing group, through direct Manufacturing or Quality Assurance roles
  • Strong technical and quality background with direct interaction with Quality Assurance, Quality Control, Project Management, and Customers
  • Good communication skills (oral and written)
  • Experience with customer interactions


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
 


Equal Employment Opportunities

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.

North America Disclosure

If you are a resident of Colorado or New York City, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

Notice on Fraudulent Job Offers

Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: https://www.emdgroup.com/en/careers/faqs.html

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