Pharmaceutical Quality Control Lead

Pharmaceutical Quality Control Lead

Pharmaceutical Quality Control Lead

Job Overview

Location
Bedford, Indiana
Job Type
Full Time Job
Job ID
42213
Date Posted
4 months ago
Recruiter
Clara Konk
Job Views
81

Job Description

As a Pharmaceutical Quality Control Lead, your responsibilities will include:

  • Keeping work area clean and maintaining a safe work environment.

  • Performing analytical testing of USP and NF products to their respective monographs. Testing samples are to be collected and tested timely and stored as required.

  • Providing ongoing API technical support to all shift laboratory technicians.

  • Responsible for the operation, maintenance, repair and trouble-shooting of API laboratory instrumentation including FTIR, Atomic Absorption (AA), and HPLC.

  • Ordering laboratory supplies including instrumentation, chemicals, glassware and various testing supplies.  Evaluating suppliers for cooperation, timeliness in response and competitive pricing. 

  • Maintaining complete, accurate and legible test records, in accordance with Company policy and record keeping procedure and ensuring all laboratory data is accurate and reliable. 

  • Analyzing, evaluating and providing recommendations on the API laboratory procedures.

  • Performing method and instrumentation validations as necessary maintaining the validated state of the laboratory.

  • Updating and creating new procedures as needed.

  • Providing back-up coverage for technician testing of both in-process and final product

  • Aiding in API laboratory Out of Specification (OOS) investigations to ensure that the investigations are thorough, timely, unbiased, well-documented, and scientifically sound and inline with FDA’s guidance for OOS investigations. Conducting and/or implementing any necessary Corrective Action to prevent reoccurrence

  • Performing other work as assigned by laboratory management.

  • Providing weekend/holiday laboratory coverage as needed.

The Quality Control Lead position is well-suited for you if you have:

  • Experience working in a Quality Control Laboratory in the pharmaceutical industry, required.

  • Experience following all safety and quality guidelines according to Good Laboratory Practices and lab safety requirements for laboratory that performs testing of an API. 

  • Capacity to solve problems through creative, innovative solutions and challenge traditional methods of accomplishing tasks.

  • Ability to build consensus and foster positive relationships. 

  • Worked as part of a technical group in a diverse work environment to accomplish a common goal.

  • Ability to learn and apply Ingredion’s Safety, GMP, Quality and Continuous Improvement standards.

Qualified candidates will have:

  • Bachelor’s degree in chemistry, or similar technical degree.

  • Possess good working knowledge of pharmaceutical laboratory practices. Minimum 5 years’ experience working in a laboratory in the pharmaceutical industry.

  • Familiarity with SAP, a plus.

  • Experience with Waters Empower, Thermo Fisher OMNIC Software, and Perkin Elmer Syngystix software, a plus.

  • Demonstrated experience operating, maintaining, and repairing API laboratory instrumentation such as FTIR, AA, and HPLC.

  • Strong written and verbal communication skills.  Ability to communicate across functional lines at all levels.

  • Decision making ability, planning and time management skills.

  • Initiative; be a self-starter and takes responsibility for personal actions, decisions and results.

Job ID: 42213

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