The QC Chemist – Raw Materials I, under direct supervision, will be responsible for assisting with raw material sampling, managing quarantine materials and prepare sample shipments for contract laboratory testing. They will also assist with supporting the Quality Control department in the release of all raw materials from the Quarantine Cage/Area for use in Non-GMP and GMP manufacturing activities for NCTM and TBF-100.
Other responsibilities may include but are not limited to: Filing folders, Managing SAP for material accountability at TBF-100 and at NCTM, ordering materials for sampling, coordinating with Materials Management/Warehouse Department on release of components and chemicals, and acquiring BSE/TSE, OAF, USP Class VI statements and/or applicable documents from vendors.
- Assist with raw material release.
- Helps prepare monthly metrics for raw material release as needed.
- Assist with sample and release of materials as needed.
- Assist with wet chemical analysis of material as needed.
- Maintain adequate inventory of supplies needed for all raw material sampling including but not limited to pipets, containers, and consumables.
- Transport and ship test samples and raw materials.
- Perform area cleaning and waste removal, as needed.
- May assist in authoring, reviewing and updating SOPs as needed; understand and follow written procedures
- Must follow good documentation practices in all aspects and phases of the work; provide reports for review in a timely manner; work with other lab personnel on projects and participate in Deviations and recommend possible corrective actions.
- Maintain the safety and orderliness of the Quarantine Cage.
- Reports excursion/out of specifications results to the QC Departmental Supervisor/Manager.
- Provides OOS investigational support as needed.
- Perform other duties as assigned.
Required Skills & Abilities:
- Apply knowledge of cGMPs on a daily basis, as applicable.
- Follow all established laboratory, regulatory, safety, and environmental procedures.
- Adhere to the standards of quality governed by current GMP's and the company Quality Policies and site SOPs.
- Ability to multi-task and prioritize work assignments with little supervision.
- Ability to accurately complete required documentation.
- Knowledge of MS Office (Word, Excel, Outlook).
- Ability to analyze raw data, assess assay and system suitability criteria.
- Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
- Utilize MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
- Excellent attention to detail.
- Ability to work in a team or independent setting and collaborate with employees from various departments.
- Computer proficiency required.
- Excellent analytical skills.
- Must have excellent organizational, written communication and oral communication skills.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, some bending, stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Ability to sit for long periods to work on a computer.
- Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
- Ability to wear personal protective equipment including safety glasses, lab coat, and gloves.
- Ability to work weekends and off-shift hours as needed to support manufacturing activities.
- Attendance is mandatory.
- Ability to lift 20 – 30 lbs involving the movement of raw materials within the quarantine cage.
- High School Diploma or GED with 2 years of experience; OR
- Associates degree
- Bachelor degree in science, supply chain, and/or related discipline
- GMP/GLP experience