Job Description

The hours for this position are Monday - Thursday 3:30pm - 11:30 and Friday 1:30pm - 9:30pm.

Summary of the Position: The QLCI reports to Quality Laboratory Management. The QLCI will provide overall support to the laboratory with testing while working in a safe work environment. This is a position that requires the ability to manage time efficiently in order to complete assigned testing. The QLCI shall be willing and able to learn laboratory processes supporting testing as well as instrumentation theory and troubleshooting.

Roles and Responsibilities:

Testing:

• The QLCI performs Release, Stability and Special Request testing of finished products and raw material samples following Standard Operating Procedures (SOPs) and in-house test methods, and/or compendial methods.
• The QLCI is expected to be capable of independently executing in-house methods and procedures and perform them as written with little to no assistance.

Teamwork:

• The QLCI must be flexible to changes with the testing schedule and adapt to laboratory improvements implemented from management and/or teammates.
• Assists with training of new laboratory personnel and document training in accordance with established laboratory SOPs and the Nutramax training program.

Safety Requirements:

• Must have a Safety-First mindset and being aware of surroundings while working in the laboratory.
• Maintains a safe work environment and will ensure that all equipment used in the testing procedures are calibrated and properly maintained.

General Responsibilities:

• Train on the operation of the following instrumentation but not limited to: Laboratory Balances, High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Automated Titrators, FTIR, UV/Vis Spectrophotometer, Polarimeter, Dissolution and Disintegration Instrumentation. The operation of additional instrumentation and the need to train on new laboratory test methods when required.
• Execute projects assigned by management within expected/established deadlines while managing time with testing responsibilities.
• Stay current on publications released by USP, FDA and other pertinent regulating bodies to ensure the Quality Laboratory complies in the areas of analytical applications, release specifications, and documentation practices. Ensure competency of ISO 17025 test methods are current.
• Assist in resolving laboratory Out-Of-Specification (OOS) results in accordance with laboratory investigation procedures if assigned.
• Perform other assigned duties as may be required in meeting company objectives.
• Communicate effectively with other departments within the organization and function within a team environment.
• Regular attendance is required.

Minimum Requirements : The QLCI will have 0 – 2 years of laboratory experience working in a cGMP environment preferred. Experience preferred with operation of laboratory instrumentation including Gas Chromatography (GC) and/or Liquid Chromatography (LC). Effective interpersonal, self-motivation skills, and the ability to interact with all levels of personnel are required.

Education and Experience: A bachelor’s degree in Chemistry. If degree has concentration; Biochemistry, Inorganic, Physical or Polymer Chemistry preferred.

Supervisory Responsibilities: None

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