Quality Assurance Technician, Floor Support

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:

The primary responsibility of the Quality Assurance Technician, Floor Support is to provide Quality Assurance oversight to manufacturing operations to ensure that production processing and other activities within the manufacturing areas are meeting cGMP requirements.
  • Monitors the filling, inspection and packaging processes, drawing AQL and other samples as appropriate, and documents results
  • Performs and documents line clearances and room releases for Manufacturing use
  • Documents and reports to management any AQL failures, GMP violations, unsafe conditions, or other unusual results or practices
  • Performs regular audits of manufacturing operations as dictated by site procedures
  • Ensure that all retained samples are logged in and stored according to standard operating procedures, as well as ensure the annual review of Finished Packaged Product Retain Samples occurs on a quarterly basis, providing a written report of results to quality management each quarter
  • Coordinate inspection of Finished Packaged Product Retain Samples for customer complaints and provide written report of results as needed
  • Inspects incoming components for adherence to quality standards, and documents results
  • Assist in inspection and labeling of raw materials
  • Work closely with Receiving and Production to ensure status is appropriate and up to date, both on the materials and in SAP
  • Performs special projects and other duties as assigned
  • 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
  • Technicians may be required to stand/walk for extended periods of time in a grade C/D classified area
12-hour rotating shift (3 days on, 2 days off, 2 days on, 3 days off) 7am-7pm

Who You Are:

Minimum Qualifications:
  • High School Diploma/GED
  • 2+ years of college coursework
  • 2+ years of experience in the pharmaceutical industry
Preferred Qualifications:
  • Bachelor's Degree in any discipline
  • 3+ years' experience in pharmaceutical manufacturing
  • Strong understanding of cGMP and GDP
  • Ability to lift and/or move up to 25 pounds
  • Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and volume
  • Ability to read and interpret documents such as quality standards, safety rules, operating and maintenance instructions, and procedure manuals
  • Ability to write routine reports and correspondence
  • Excellent interpersonal and team skills
  • Ability to work independently and carry out QA decisions based on GMPs and appropriate procedures
  • Familiarity with Quality Management computer systems such as Trackwise & SAP

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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