Job Description

GENERAL PURPOSE OF JOB:

This position is responsible for providing technical support and leadership within the Quality organization, as well as coordinating Quality activities in line with FDA and other regulatory requirements.

JOB RESPONSIBILITIES:

  • Directly supervise the Quality Assurance Analysts to insure the proper level of support is provided throughout the plant.
  • Oversee the required training for new lab analysts.
  • Coordinate and assign daily work priorities within the laboratory
  • Ensure timely completion and reporting of all analyses to support product release
  • Ensure timely completion of all required plant safety training.
  • Performs required testing to support all production requirements including Raw Materials, Intermediate and Finished Products.
  • Maintain the LIMS database.
  • Oversees the Retention and Stability Sample program
  • Manage and order all chemicals and reagents.
  • Maintain proper calibration of scales and all lab instruments.
  • Maintain tracking of material Expiration/Retest dates
  • Assure compliance with Company and Government regulations.
  • Provides analytical support to Validation Protocols. 
    • Insures all required testing is completed and reviews data as necessary for summary reports.  Insures all specifications and new methodology is in place to support the start of production.
  • Initiates LIRs and Non-Conformance reports for Raw Materials, Intermediate products and finished products.
  • Authors and approves SOPs and Work instructions to support quality systems.
  • Participate in root cause investigations on product failures and recommends corrective/preventative actions to resolve the failures.
  • Provides support to internal and external customers regarding quality related issues.

Qualifications:

Basic Minimum Requirements:

  • Meet the legal minimum age requirement
  • Authorized to work in the United States
  • Bachelor of Science Degree in Chemistry or related field
  • 3 years experience working in a cGMP regulated facility             
  • 3 years experience performing analytical testing involving wet chemistry related applications      
  • 2 years experience in preventive maintenance, calibration and troubleshooting of analytical lab instruments
  • 2 years supervisory experience
  • Ability to work all shifts
  • Ability to work overtime as needed

Other Required Skills:

  • Ability to work independently and as part of a team
  • Strong attention to detail, planning and organizational skills
  • Strong written, verbal and interpersonal skills

Preferred Qualifications:

  • 2 years experience working with LIMS
  • 2 years experience in Technical Writing (i.e. methodologies, SOPs, LIRs)

Physical Requirements

  • Able to sit for long periods of time utilizing a computer
  • Able to stand for long periods of time
  • Lifting up to 25 lbs

Application Instructions

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!

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