cGMP Operations Compliance Specialist

Posted 21 Dec 2022

St. Louis, Missouri - United States

Req Id 257756

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 Operations 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 review.

ESSENTIAL JOB FUNCTIONS

  • Coordinate documentation and tasks associated with equipment and facilities:
    • Change management
    • Addition of new equipment
    • Calibration
    • Non-Conformances and CAPAs
  • Review production documentation and perform regular Quality Walk-throughs during manufacturing events
  • Work with Manufacturing, Technical Operations, Maintenance, Engineering, Validation, Warehouse/Packaging, and Quality Assurance to ensure that change controls, deviations, & CAPAs are reviewed, approved and implemented as appropriate
  • Lead and/or assist with equipment and facility investigations, troubleshooting and root cause analysis
  • Lead and/or assist with equipment and facility risk assessments
  • Maintenance of quality systems and cGMP compliance
    • Understand regulatory requirements such as ICH Q7
    • Support 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
    • Assist in the generation of manufacturing CAPA, deviation and change control trend reports
  • Drive continuous improvement to support customer and regulatory expectations
  • Engage in face-to-face discussions with customers and regulatory authorities in support of customer visits, audits, and regulatory inspections.

 

Who You Are:

Minimum Qualifications:

  • 3+ years of experience supporting GMP Operations in a Quality related capacity
  • 2+ years of experience in quality systems administration (Change Control, Deviations, etc)

 

Preferred Qualifications:

  • Bachelor’s degree in Chemistry, Biochemistry, or other Life Science field of study.
  • 5+ years of experience supporting a GMP Manufacturing group, through direct Manufacturing or Quality Assurance role.
  • Strong technical and quality background.
  • Direct interaction with Quality Assurance, Quality Control, Project Management, and Customers is expected; Therefore strong communication skills (oral and written).
  • Apply and incorporate pharmaceutical standards and rules, as per ICH Q7, into documents and day-to-day practice. 
  • Identify potential safety, quality and compliance risks associated with technology transfers / scale-up projects, and propose solutions to mitigate risk prior to GMP Manufacturing operations.
  • Highest level of professionalism and responsibility.
  • Experience with customer interaction.
  • Intermediate knowledge in chemistry, biology, biochemistry, and math, as well as an understanding of current Good Manufacturing Practices.


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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