** Degree in Chemistry required **
The quality control chemists perform testing on raw materials, bulk formulations, finished products, stability samples, and any other samples from plant operations that require chemical analysis. The QC chemists report to the QC manager.
- Responsible for the laboratory testing in accordance with company SOP’s as well as cGMP’s and GLP’s
- Testing involves Raw materials, In-process, Finished product, and Stability samples for potency and physical characteristics such as pH, Specific gravity, Moisture, etc.
·Maintains lab work area in a neat and ordered fashion
- Proficient with the operation of instrumentation such as HPLC, UV, GC, KF, AA and FTIR
·W -Works in support of production may require weekend or off-shift work
- May require overtime as necessary to complete high priority work assignments
- Has minimal customer interaction
- Responsible for additional assigned laboratory duties such as maintaining an inventory of consumable supplies
- Maintains data within a laboratory notebook in a neat (legible) and organized manner
- Records entries in laboratory logbooks as necessary
- Generally works in agreeable conditions. May require extended periods of standing or sitting. Requires the ability to wear a respirator or breathing apparatus
- Performs work in accordance with general and specific safety precautions
- Responsible for the peer review of co-workers notebook to ensure compliance to SOP’s and cGMP’s
- Responsible for ensuring safety and integrity of product testing in the department
- Works in a fast paced, moderately stressful environment. Adherence to project deadlines is critical
- Interacts with other departments such as Production, QA, R&D on a minimal basis
- Consolidates all notebook pages and chromatographic scans with the QC section of the batch record and forwards results to documentation
- Reports to the QC supervisor for assignments and annual review
- Assists with the orientation of new employees
- On occasion works with assignments such as method transfer, validation, and accelerated stability testing
- Initiates DCR’s to correct or clarify SOP’s
- Requires the ability to work with computers as well as proprietary software
- May require sampling of active substances and excipients
- Responsible for maintaining confidentiality of work assignments
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND EXPERIENCE:
A BS/BA degree in Chemistry or Chemical Engineering is required. Two years of industry experience involving analytical or wet chemistry test procedures in a Quality Control environment is preferred but not necessary.
- Requires superior writing skills.
- Requires exceptional attention to detail with the ability to focus on current assignments. While Laboratory mistakes are unavoidable they must be kept to a minimum due to their ramifications.
- Requires initiative and self-motivation with moderate supervision in a detail-oriented manner.
- Requires the ability to work on multiple projects in a concurrent manner.
- Must possess the ability to work in an independent manner, as well as a group environment.
- Satisfactory completes initial and annual training for cGMP and corporate operating procedures.
PHYSICAL DEMANDS AND WORK ENVIRONMENT:
While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use. The employee is required to work in a cubicle. The noise level is usually fairly quiet.