QC Sample Coordinator

Full Time
Indianapolis, IN
Posted
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.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:
This is a laboratory administrative position that will be responsible for receiving samples for QC testing, creating governing testing documentation, coordination of testing with contract labs, managing laboratory supply inventories and service contracts and purchase requisitions. Additionally, responsibilities will include routine laboratory testing as needed.

Position Activities & Responsibilities:
  • Performs the receipt, storage, and submission of test samples for the QC laboratories
  • Responsible to creating test submission packets for samples that require QC testing as part of batch records, special test requests, routine SOP testing, and protocols
  • Responsible for coordination of testing with contract laboratories, and submission of samples to contract laboratories and reporting results from contract testing
  • Maintains and manages inventory of department materials and supplies. This includes reference standards, reagents, and consumables
  • Communicates with Corporate Legal, Finance, Procurement, and vendors to initiate and manage QC Purchase Requisitions, Service Contracts and Statements of Work
  • Coordinates with ATS, Validation and Technical Support departments for sample receipt and management for cleaning validation, process validations, method validations, method transfers and other QC support testing
  • Assisting with routine QC Chemistry laboratory testing as needed in an Analyst function
  • Mentoring and training of junior QC Analysts on methods and laboratory systems
  • Revision of QC laboratory SOPs
  • Performs special projects and other duties as assigned
  • As a part of the employee's job requirements, the employee may be required to handle wastesincluding 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
  • Responsible for adhering to the Environmental, Health, and Safety program
  • Individual contributor in the role of QC Chemistry laboratory management support
**This is a 2nd shift position: Monday-Friday 2pm-1030pm**

Who You Are:

Minimum Qualifications:
  • Associate's Degree in Chemistry, Biology or other life science discipline
  • 5+ years cGMP laboratory experience
Preferred Qualifications:
  • Bachelor's Degree in Chemistry, Biology, and other life science discipline
  • Experience with NuGenesis lab management system
  • Attention to detail, high functioning organizational and time management skills
  • Proficient using Microsoft Office software including Word, Excel, and Access
  • Solid cGMP expertise in testing/manufacturing environments
  • Technical knowledge of bio-analytical and chemistry analytical techniques
  • Familiarity with analytical validations, method transfers, cleaning validations, and scientific research
  • Demonstrated ability to perform analytical testing using the majority of the analytical equipment used in the analytical laboratory including HPLC, GC, TLC, UV/VIS Spectroscopy, FTIR Spectroscopy, Particle Size, Electrophoresis
  • Working knowledge of Empower
  • Ability to communicate at all levels in a pharmaceutical organization
  • Good interpersonal skills
  • Ability to perform functions as itemized in physical and environmental requirements of the job

RSRMS

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

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