Assistant Quality Supervisor

1 week ago

Lawrenceburg, Indiana, United States Catalent Inc Full time
Job Summary

We are seeking an experienced Assistant Quality Supervisor to join our team at Catalent Inc. As a key member of our quality assurance team, you will be responsible for leading dietary supplement and food manufacturing QA activities in line with Food Safety and 21 CFR 111, 117, and 11 Quality programs.

Key Responsibilities
  • Conduct routine GMP internal audits and daily checks, issue batch records to the manufacturing and packaging floor.
  • Review executed batch records and address issues found with other departments during their shift.
  • Support customer, certification, and regulatory audits as required.
  • Ensure compliance with SQF requirements, monitoring of critical control points per the HACCP Plan and current Catalent SOPs.
  • Collect and submit product, water, surface, and air samples, and review COAs from third-party labs against current specifications.
  • Conduct effectiveness checks to confirm corrective actions were implemented to prevent reoccurrences.
  • Create and assist operations in the initiation of incident reports, deviations, investigations, and ensure appropriate follow-up and corrective actions.
  • Provide training and guidance to quality assurance specialists on a day-to-day basis and set priorities for the team to ensure task completion, coordinate work activities with other department leaders.
  • Provide coverage during production runs on extended shifts and weekends.
  • All other duties as assigned.
Requirements
  • Bachelor's degree in food science/food technology, biology/chemistry preferred.
  • Prior experience in a food processing or dietary supplements manufacturing environment under 21 CFR 111, 117, 11 HACCP, and SQF required.
  • Demonstrated leadership experience. Direct people management experience required.
  • Must work well in a team-based environment as well as work alone on various projects.
  • Strong leadership skills, proven experience as a team lead/people management experience.
  • Ability to analyze processes for biological, chemical, and physical hazards at each step of a production process.
  • Ability to work with cross-functional departments within the organization.
  • Good problem-solving, verbal, and communication skills, excellent analytical and decision-making abilities. Ability to prioritize and follow through to achieve results and meet deadlines.
  • While performing the duties of this job, the employee is regularly exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate to loud.
  • The employee must be able to lift and/or move up to 50 pounds. While performing the duties of this job, the employee is required to use hands to finger, handle, or feel and is frequently required to stand, walk, reach with hands and arms, stoop, kneel, crouch, or crawl, and talk or hear. The employee is required to sit, climb or balance, and taste or smell.
Why Catalent?
  • Competitive medical benefits and 401K.
  • 152 hours of PTO + 8 Paid Holidays.
  • Dynamic, fast-paced work environment.
  • Opportunity to work on Continuous Improvement Processes.
About Catalent
Catalent is a global drug development and delivery leader that helps bring over 7,000 life-saving and life-enhancing products to patients around the world. We are an exciting and growing international company where employees work directly with pharma, biopharma, and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

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