QC Compliance Lead

Merck

Indianapolis, IN, USA

Full time

Jan 24

Full Job Description

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:

This QC technical support position is responsible and accountable for QC sample management, driving laboratory root cause investigations, management of transfer of RDM methods into QC, and proposing appropriate CAPAs and the technical review of data generated from finished products, in-process

samples, stability samples, and raw material samples against cGMP compliance, approved procedures, and method validations/verifications and/or compendial requirements. This position includes laboratory testing.

Major Position Activities & Responsibilities:

  • As assigned, perform, and drive in-depth laboratory investigations to completion. Determine root cause and propose appropriate CAPAs.
  • As assigned, perform laboratory testing to support raw material, in-process, finished product and stability sample release.
  • Provide SME support for electronic QC database systems and laboratory data integrity compliance (Empower, Nugenesis, SampTrak) to support the QC laboratories.
  • Provide support for instrument troubleshooting, instrument repair, and instrument calibrations for the QC laboratories.
  • Serve as a Qualified Scientist when needed by performing an in-depth technical review of all analytical and microbiological testing performed on finished products – in-process samples, stability samples, raw material samples, and environmental samples, ensuring compliance with GMPs.
  • Assist laboratory management as a mentor in the development of all levels of analysts in the laboratory. This mentorship includes technical guidance regarding GMP fundamentals, chromatographic/spectrographic systems, and general analytical testing.
  • Provide laboratory information and documentation requests to site management and CM customers required for regulatory filings and product import/export needs, when required
  • Review product trends and identify out-of-trend results
  • Assess method reliability and trend data for inclusion in PQR/APR
  • Revise and improve analytical methods, protocols, and associated SOPs
  • Participate in and adequately represent the QC laboratories in customer and regulatory audits of the facility.
  • Manage the transfer of RDM methods into the QC laboratory for early phase products. Work with QC and QA to ensure success of these transfers.
  • Participate in and lead projects for continuous improvements in methods or method execution.
  • As a part of the employee’s job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.

Scope:

Individual contributor providing technical support to the QC chemistry and microbiology laboratories.


Who You Are:

Minimum Qualifications:

  • Position requires a Bachelor’s degree in chemistry or related field with a Master’s degree preferred.
  • Seven years or more of pharmaceutical industry experience and six years or more of Quality Control experience required.
  • Extensive experience in chromatography methods (e.g., HPLC, UPLC, GC) and technologies required. In addition, experience with UV/VIS Spectrophotometry, FTIR Spectrophotometry, and other analytical techniques will be required.


Preferred Qualifications:

  • Extensive experience in chromatography integration software (e.g., Empower, ChemStation, Chromeleon, Totalchrom).
  • Proven skills coaching/mentoring technical laboratory staff in a GMP/GLP laboratory environment.
  • Method transfer and method validation experience desired.
  • The position requires proven ability and skill in analyzing, understanding and presenting technical data.
  • Experience in technical writing, communicating across organizational levels, and data analysis and trending is expected. Good interpersonal skills are a must.


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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