Chemist, Quality Control
Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our expanding team. This is an exciting opportunity to play a critical role within our organization that is driving advanced therapy development and commercialization with high quality industrial scale solutions. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.
Quality Control (QC) Chemist will perform various QC analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance with established specifications/standards. Conducts validation of biological and chemical QC assays. Quality Control Chemist compiles, interprets, and documents data from testing processes to either confirm compliance with established quality standards or identify deviations. In addition, he/she is responsible for writing/revising Standard Operating Procedures, assay methods validation and instruments qualification IOPQ. The Quality Control Chemist gains exposure to some of the
- Perform testing for incoming material, in-process product and final product, and stability as detailed per SOPs and/or client’s/customers specifications, as applicable.
- Conducts investigations (deviations and OOSs) as applicable for areas of responsibility.
- Interacts regularly with senior technical peers and colleagues in all departments especially in development, production and quality.
- Performs instrument calibrations, qualification and general preventive equipment maintenance. Contribute to maintaining lab and equipment cleanliness.
- Initiates and manages stabilities studies/protocols and reports.
- Writes and revises Standard Operating Procedures (SOPs) and validation protocols
- Prepares finished products Certificate of Testing and Certificate of Analysis.
- Trends/analyzes Akron’s in process/release data.
- Assists in the recommendation of new methods for testing efficiency.
- Creates an environment that encourages problem solving at the individual and team level.
- Performs duties in accordance with established laboratory standards. Evaluates, troubleshoots, and solves routine problems. Interprets data based on knowledge and experience.
- Accountable for following SOPs and adhering to cGMP guidelines as applicable to the ancillary material guidelines and regulations.
- Conducts tasks with minimal supervision.
- Performs other duties as assigned.
- BS in Chemistry, Biochemistry, Microbiology, Biology, or other related science discipline.
- 4 years minimum relevant experience in laboratory setting.
- Experience writing protocols required.
- Experience in one or more of the following analytical instrumentation: HPLC, GC, UV spectrophotometer, IR spectroscopy, microscope, plate reader, and densitometer.
- Perform math calculations involving dilutions, fractions, decimals and percentages.
- Experience in quality organizations supporting production, testing, release, and distribution of cGMP products.
- Experience conducting investigations (deviations and OOSs) as applicable for the testing performed.
- High attention to detail with good time management and organizational skills.
- Ability to work well under pressure and prioritize assignments in a multi-task position.
- Motivated and able to work independently.
- Excellent verbal communication skills and people/customer service oriented.
- Basic knowledge of Word, Excel and Software Programs.
- Requires a strong adherence to regulatory compliance and safety requirements, involving GMPs, SOPs and other related documents such as logbook.