QC Supervisor

Leiter's

Englewood, CO, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 12/25/2020
  • Website: leiterrx.com
  • Company Address: 17 Great Oaks Blvd, San Jose, CA

About Leiter's

Leiters, founded in 1926, is a trusted FDA-registered 503B outsourcing provider of high-quality hospital and ophthalmology compounded sterile preparations. Leiters is committed to providing healthcare professionals and their patients with high quality outsourced medications. Our team of experts in sterile pharmaceutical manufacturing, repackaging and compounding provide a sophisticated understanding of what it takes to elevate quality and consistency of supply in pharmaceutical outsourcing. The combination of a highly experienced team, with robust processes in a new state-of-the-art outsourcing facility, helps to ensure delivery of the highest quality medicines. All sterile preparations are produced under the Human Drug Outsourcing Facilities under 503B of the FD&C Act (503B Guidance) and follow Current Good Manufacturing Practices (cGMP).

Job Description

This position will report to the Site Quality Manager. The Quality Control Supervisor executes testing, and monitors the Quality Control activities in an outsourcing facility.
The position is responsible for the assurance that the drug product has the safety, identity, strength, quality, and purity represented. The candidate should have an excellent understanding of cGMP requirements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality control, attention to detail, and excellent communication with other functional areas and sites.
ESSENTIAL FUNCTIONS:
  • Review and release incoming items intended for production use in relation to their specifications.
  • Review and approve testing performed for finished products in relation to their specifications.
  • Draft and review sampling instructions, specifications, test methods, quality control procedures, and standard operating procedures for applicability at both the third party testing facility and production use.
  • Investigate out of specification results from testing performed.
  • Ensure that the appropriate validations, including those of analytical procedures, and calibration of control equipment are carried out.
  • Investigate reprocessing/rework of products, complaints, analytical failures, and returns/salvages.
  • Supporting internal and external audits as needed.
  • Create and revise documents as needed.
  • Identify trends in the industry and recommend improvements.
  • Work with a team to ensure that the systems involved in an outsourcing facility are in a state of control
  • Other duties as assigned to ensure appropriate quality practices
SUPERVISORY RESPONSIBILITIES:
  • Supervise Quality Control technicians
EXPERIENCE AND NECESSARY SKILLS:
  • Knowledge and experience with the US FDA cGMPs, preferably in a commercial compounding outsource facility
  • Knowledge of compounding techniques and controlled environments
  • Knowledge of appropriate materials and conditions
  • Able to identify potential adverse issues
  • Excellent organization and documentation skills
  • Detail oriented
  • Computer skills, including Microsoft Word and Excel
  • BS or BA degree (in a scientific discipline desired)
  • Able to lift up to 20 lbs and stand for up to two hours when required

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.