Position Summary:
Responsible for the oversight of Quality Control functions related to raw materials, including but not limited to: testing and release of raw materials, approval of new raw materials, maintenance of raw material methods, and training of chemists. Group leader shall perform tests using HPLC, ICP, FTIT, NIR, UV-VIS and wet chemistry per USP, AOAC, FCC, BP (British Pharmacopeia) and internal procedures. Properly disposes of waste chemicals based on OSHA requirements.
Position Scope: Lead a team of 3-4 chemists in various QC functions related to raw materials.
Position Responsibility:
- Establish and maintain raw material specifications in accordance with acceptable guidelines such as those in the USP, FCC, and AOAC.
- Ensures the training of chemists on various lab instruments required for the analysis of raw materials.
- Implement and maintain new raw material approval process which includes: reviewing supplier provided documentation, verifying supplier CoA results, and establishing in-house specifications. Incumbent shall work closely with other departments to review all criteria prior to the approval of a material for purchase.
- Communicates directly with raw material suppliers to deal with any issues or changes with raw materials.
- Assures the quality of incoming raw materials by coordinating testing, reviewing and checking of specifications. Works closely with Supply Chain and Operations to release materials prior to their need dates.
- Prepares and files all Quality Control documents, e.g. change controls, certificates of analysis, deviations, specifications, and out of specification reports.
- Works with supervisor and manager to perform out of specification investigations.
- Works with supervisor and manager to enforce GLPs in the lab.
- Maintains R&D raw material inventory, laboratory notebooks, equipment logs and maintenance schedules.
- Qualification and maintenance of primary and secondary standards of raw material and finished products.
- Works with Supply Chain and Operations to evaluate expired materials for re-test or disposal.
- Assists in the inventory of supplies and upkeep of laboratory and laboratory equipment.
- Assists with overseeing the preparation of purchase orders, receipt of supplies, and interfacing with other departments to expedite these functions.
- Develops, maintains, validates, and implements lab methods.
- Performs analytical troubleshooting and updates SOPs, log books and lab solutions preparation book.
- Provides guidance and training for Chemists I, II and senior chemist.
- Must enforce Personal Protective Equipment (PPE) program as stipulated by SOPs. e.g. respirator, ear plugs, hair net, beard cover and lab coat.
- Maintains professional and technical knowledge by attending educational symposia; reviewing professional publications; establishing personal networks; participating in professional societies, etc.
- Assures compliance by following Food and Drug Administration's Good Manufacturing Practices (FDA cGMPs / GLPs) as well as other regulatory standards as required by the department.
- The above is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management.
QUALIFICATIONS
Experience and Skills:
- 5 years of analytical chemistry lab experience and/or 5 years of experience working in FDA/EPA and OSHA regulated agencies. Minimum of 1 year in leadership role.
- Computer Experience both PC- MS Office, word, excel, Outlook & Mainframe systems
- Excellent leadership and communication abilities
- Ability to work in a team environment
Education and Certifications:
- BS or BA in science related field