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Quality control supervisor

Leiters

This is a Full-time position in Englewood, NJ posted February 7, 2020.

Looking for an exciting pharmaceutical career?

Leiters has an opportunity for you!

We are now hiring Quality Control Supervisor for our Englewood, Colorado facility, which is located 20 minutes south of Denver.Benefits start the first of the month following your hire date, and include 401(k) with a 4% company match.This description is intended to be illustrative of the major duties performed by the employee assigned to this position.

Performs other duties as assigned.

GENERAL 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 practicesSUPERVISORY 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 requiredClick “Apply now” to upload your resume and apply online today!About us:Leiters, founded in 1926, is an FDA-registered 503B outsourcing provider of high-quality ophthalmology and hospital-based services.Leiters is an Equal Opportunity Employer.