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Quality Control Chemist -Pharmaceutical Manufacturing

Company: HireResources (WO New)
Location: Largo
Posted on: June 7, 2021

Job Description:

Job Description

Quality Control Chemist III

Quality Control

Reports to the Quality Control Supervisor

Location - Largo, FL

The QC Chemist III is responsible for supporting the companys Quality Control related requirements. This includes the performance of area responsibilities necessary to ensure that Laboratory activities are in accordance to cGMPs and FDA requirements. This individual performance must be aligned and consistent with company objectives, applicable department programs, including training, documentation, standard operating procedures, and policies and procedures.

Performs analytical testing of raw materials, in-process samples, finished products and stability samples in accordance with company SOPs and established cGMP and safety guidelines.

Prepare Test Solutions as per established test methods and/or compendial requirements

Conduct advanced, compendial-based wet chemistry testing of raw materials and components (e.g. <231> Methods I and II, potentiometric titration, dissolution) consistent with established methods/specifications as well as USP/NF

Conduct advanced chromatographic analysis (e.g. HPLC/GC related substances and GC residual solvents) as part of raw material/in-process/finished product testing

Execute compendial method verification protocols and report results to the QC Analytical Support Group

Train QC staff, where qualified to serve as a trainer

Execute analytical method transfers and/or participate in co-validation efforts with Analytical Research and Development (AR&D) or Quality Control Analytical Services (QCAS)

Participate in departmental projects as assigned by laboratory management, including Lean and Process Excellence Initiatives.

Assist with the implementation of new technology

Initiate change controls and document change requests as directed by laboratory management and ensure their timely approval/closure

Documents the procedures and results obtained in laboratory notebooks/logbooks according to established procedures consistent guidelines.

Assists in calibration and maintenance activities of instruments as directed by lab management.

Demonstrate proficiency in QC Chemist I and QC Chemist II job requirements.

This position may require the labeling, packaging, or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained in these subjects as per applicable local, state and/or federal regulations.

Adheres to all applicable procedures, cGMPs, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, HS&E, etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Safety goals.

Quality Management, as required, may assign, and require other duties and responsibilities not previously mentioned above.

Perform all other duties as may be assigned by management.

No associates report to this position, however, may be required per Management request to lead on laboratory or site initiatives.


BS Degree or higher in Chemistry or related science field (or equivalent) a minimum of five (5) years of related work experience in a pharmaceutical, chemical, or related industrial working environment.

Must have strong background in HPLC (High Pressure/Performance Liquid Chromatography) and GC (Gas Chromatography) instrumentation

As part of your job duties, travel between buildings is required on a routine basis. If applicable, you will be compensated at the current IRS mileage reimbursement

Company Description

Growing company

Keywords: HireResources (WO New), Largo , Quality Control Chemist -Pharmaceutical Manufacturing, Other , Largo, Florida

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