Sr. Quality Control Assistant - Chemistry
Let’s Make Things Happen!
Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies.
Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the industry’s top leaders for cGMP microbial fermentation of recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.
Now is an exciting time to join Althea. We have talented people working together to help our clients advance their innovative product pipelines. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth.
Our work atmosphere is fast paced, stimulating and customer focused. Employees take pride in knowing our efforts are helping countless patients for years to come.
Althea is currently seeking a Sr. Quality Control Assistant - Chemistry, to be responsible for conducting routine analysis of raw materials, in process and final product under moderate supervision. The Sr. QC Assistant - Chemistry may focus in a specialized area and provide routine analysis and testing according to standard operating procedures in any of the following areas: in process and finished formulations, cleaning samples, and perform qualifications and transfers of methods.
- Conducts routine analysis and testing of samples under general supervision and may focus analysis and testing in a particular QC arena.
- Performs assays. Releases testing assays for in process, final product, raw materials and other routine samples.
- Adheres to cGMP requirements and SOPs.
- Compiles data for documentation of test procedures.
- Responsible for standardization and maintenance of laboratory equipment.
- Reviews data obtained for compliance specifications and reports abnormalities.
- Reviews batch records and product specifications as required.
- Maintains lab area including routine cleaning of benches, biosafety cabinets, shelving and floors.
- Collects and disposes of lab wastes according to established procedures.
- Assists in the transfer, qualification and validation of new testing methods with guidance from supervisor.
- Assists in IQ/OQ/PQ of new instruments with guidance from supervisor.
- Revising and writing of SOPs and qualification protocols.
- Embodies Althea’s cultural values and aligns daily actions with department goals and company culture.
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- High School Diploma or equivalent required. Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent.
- Minimum of two (2) years of relevant experience in laboratory or quality control.
- Ability to perform testing in a highly accurate and reproducible manner.
- Familiarity with cGMP, manufacturing, machine operations, troubleshooting, and data entry.
- Detail oriented with strong written and verbal communication skills.
- Ability to work independently, within prescribed guidelines, or as a team member.
- Demonstrated ability to follow detailed directions in a laboratory environment.
- Must be familiar with Microsoft Office applications.
If you meet the requirements above, and would like to apply for this position, please visit our website at www.altheacmo.com and click on the "Careers" section. Please be sure to note where you saw our ad posting.
We are an EOE dedicated to a diverse work force and Drug Free work environment.
Qualified M/F/D/V candidates are encouraged to apply.