QC Supervisor, Kansas City, MO

Nostrum Laboratories
Kansas, MO Full Time
POSTED ON 8/13/2024 CLOSED ON 10/5/2024

What are the responsibilities and job description for the QC Supervisor, Kansas City, MO position at Nostrum Laboratories?

General Summary Description

The QC Supervisor is responsible for coordinating, planning and monitoring all activities of the Quality Control Department to ensure QC laboratory operates following written procedures, ICH & cGMP Guidelines.


Duties and Responsibilities

  • Responsible for review and quality control release of raw materials,, in-process, finished products, and stability testing for drug substance and drug products.
  • Oversees the scheduling for testing.
  • Ensures all laboratory personnel are properly trained, have the proper knowledge and skillset to complete day to day activities with quality, integrity, and compliance.
  • Manages laboratory investigations to ensure accuracy, scientific rationale and completed in a timely fashion.
  • Coordinates with instrument calibration program to safeguard all equipment used in the laboratory is within calibration, and routine maintenance has been performed.
  • Reviews and/or updates changes to SOP(s)/STM(s)/Annexures and/or specifications related to QC.
  • Troubleshoots QC instruments.
  • Assists in data processing for integration.
  • Assist in Stability Pull dates, Stability Testing due dates and Stability Review dates.
  • Initiates all laboratory investigations (non-LIR & LIR) and develops investigational plan.
  • Reviews final report which goes to QA for final disposition.
  • Assists with returned goods investigations, product complaint investigations, and product recalls.
  • Performs other duties as assigned .


Direction Received
:
Organize own work with very little direction

Analytical Requirements
:

Decisions and Judgment
:
Primarily manages a department/division including interviewing, selecting and training employees. Directs work and appraises performance of 2 or more full-time regular employees with the authority to hire, fire and recommend advancement or promotion

Initiative
:
Independent action within an established field is required; new procedures and new approaches to problems must be assigned




Minimum Qualifications


Bachelors Degree in Chemistry, Pharmacology, Pharmaceutics, Biology or related field with 5-8 years cGMP requirements experience in pharmaceutical, biotech, and/or medical device industry required. Masters degree and 2-5 years experience preferred.


Additional Requirements



Licenses/Certification
:
  • None

Special Requirements/Skills
:
  • Ten-key calculator by touch
  • Ability to use general office equipment
  • Proficient in Microsoft Word and Excel
  • Knowledge of Balance, Dissolution Bathes, AA, and HPLC
  • Strong communication skills
  • Exceptional attention to detail
  • Basic typing skills
  • Excellent supervisory skills

Work Environment
:
  • Office environment
  • Laboratory environment

Qualified Applicants:


Please Contact:

Shari Rapposelli
Nostrum Laboratories, Inc.
1800 N. ping Ave.
Kansas City, MO 64120



Send resumes to HR Manager at Nostrum Labs, Inc. to hrinfo@nostrumlabs.com
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