GMP Manufacturing Training Specialist 2

Posted 06 Feb 2024

St. Louis, Missouri - United States

Req Id 271939

 

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:  

 

At MilliporeSigma, as the GMP Manufacturing Training Specialist 2 at our Cherokee site/3300 S. Second Ave, St Louis, you will be expected to design, develop, facilitate and lead staff training programs and initiatives while fostering a collaborative learning culture. You will oversee the training performance and compliance within operations.  You will be responsible for oversight of the training curriculum within GMP Operations, in addition to continuous improvement of the training systems to ensure they remain consistent with current expectations for manufacturing staff.  This position requires technical knowledge pertaining to GMP Manufacturing and associated quality regulations, training development and delivery, change management, and strong analytical skills.  

 

The cGMP Manufacturing Training Specialist 2 position is a key role within our GMP Operations Systems & Support team, which also includes Facility Support, Manufacturing Compliance, and our GMP Packaging team.   Expectations of the GMP Operations System & Support team is to ensure “Compliance” and “Readiness” within our GMP Manufacturing teams, ultimately enabling high manufacturing success.  

 

We are looking for a candidate with a passion for success enabled through training and development of employees through administration of programs that will improve skills and knowledge. 

 

  • Train staff on GMP production plant manufacturing techniques for APIs and intermediates and effectively operate and demonstrate proper use of production equipment
  • Train staff in manufacturing safety and quality best practices and GDP for manufacturing records (batch records, logbooks, etc.
  • Create and track key performance indicators demonstrating successful training compliance
  • Lead onboarding activities and processes for new Operations staff
  • Partner with the Manufacturing and Quality group to sustain and establish new standards and approaches around training
  • Deliver group and individual instruction and training covering a range of technical and/or operational area
  • Work with Operations managers to develop training curricula and programs that meet instructional goals and objectives
  • Formulate training outlines and determine instructional methods, utilizing knowledge of specified training needs and effectiveness of such methods as individual training, group instruction, lectures, demonstrations, conferences, meetings, and workshops.
  • Select and/or develop training aids, including training handbooks, demonstration models, multimedia visual aids, computer tutorials, and reference works
  • Provide administrative oversight necessary to establish, execute and document training programs
  • Initiative to make recommendations and influence changes with the training program and implement
  • Identify and implement improvement projects that improve skillset of senior employees and subject matter experts
  • Lead Train the Trainer initiatives to expand training knowledge and ability of senior staff and subject matter experts
  • Serve as the Operations Training subject matter expert during customer audits and regulatory inspections
  • Evaluate effectiveness of training and development programs and utilizing relevant evaluation data to revise or recommend changes in instructional objectives and methods
  • Ability to create a robust training approach by analyzing and assessing training and development needs for individuals, teams and overall GMP Operations
  • Work effectively cross-functionally by interacting daily with colleagues across the site
  • Complete/assist with deviations and CAPAs related to training program

 

Who You Are:

 

Minimum Qualification:

  • Bachelor’s Degree in any discipline 
  • 4+ years experience in a pharmaceutical GMP operations environment (Manufacturing, Quality, MSAT)
  • 2+ years experience in a training role/function

 

OR

  • High school diploma or GED
  • 10+ years experience in a pharmaceutical GMP operations environment (Manufacturing, Quality, MSAT)
  • 2+ years' experience training role/function

 

Preferred Qualifications

  • Experience working with Training systems to track and evaluate compliance management and program effectiveness
  • Strong interpersonal and communication skills and the ability to work effectively within a team environment
  • Ability to lead discussions and instruct participants in training classes using a variety of instructional techniques
  • Ability to gain consensus and drive positive change
  • Analytical mindset with the ability to assess training effectiveness
  • Strong teaching and facilitation skills.
  • Ability to determine training objectives.
  • Ability to design, develop, implement, and evaluate training plans, curricula, and methodology
  • Strong knowledge of GMP API manufacturing
  • Detailed oriented with a future oriented mindset
  • Possess a high degree of motivation and are a self-starter with initiative to Think Outside the Box
  • Proficiency with ManGo, Trackwise, and SAP systems
  • Prior training experience in an API manufacturing environment
  • Demonstrated process improvement experience
  • Familiarity with FDA, EMA, and other regulatory standards
  • Demonstrated knowledge and experience in various computer skills, including Windows (Word, Excel, PowerPoint, etc.)


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


US 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.

We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.


North America Disclosure

If you are a resident of California, Colorado, New York, or Washington, 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.


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