Quality Control Chemist
Company: Akron Bio
Posted on: August 2, 2022
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/revisioning Standard Operating Procedures,
assay methods validation and instruments qualification IOPQ. The
Quality Control Chemist gains exposure to some of the complex tasks
within the job function. General Requirements
- 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
- Performs instrument calibrations, qualification and general
preventive equipment maintenance. Contribute to maintaining lab and
- Initiates and manages stabilities studies/protocols and
- Writes and revises Standard Operating Procedures (SOPs) and
- 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
- 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
- Conducts tasks with minimal supervision.
- Performs other duties as assigned. Requirements
- 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
- 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
- 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. EOE/DFW
Keywords: Akron Bio, Sarasota , Quality Control Chemist, Other , Sarasota, Florida
Didn't find what you're looking for? Search again!