The Quality Control Analyst I is responsible performing assays and reviewing data from the analysis of samples to support Product Operations and for verifying that products meet specification for release and/or stability. This position is also responsible for transferring assays from R&D to QC, as applicable, for new product biology assays.
Duties and Responsibilities
- Perform assigned biological quality control and/or stability analysis of samples obtained from Product Operations as specified by approved SOPs and/or Methods. Testing includes, but is not limited to, trypan blue cell counts, enzyme characterization incubations, protein analysis, MTT, cell confluence and plateability.
- Assist in revision of SOPs and/or Test Methods as applicable.
- Maintain accurate and concise documentation of testing conducted and resulting data. Review data obtained for compliance to specifications and report abnormalities
- Ensure all laboratory documents are completed within specified timelines.
- Accurately maintain appropriate quality control files and QC databases.
- Work with manager or Sr. QC Analyst to conduct laboratory investigations related to product testing where required.
- Prepare release documentation (Product Data Sheets/Certificates of Analysis) as required.
- Accurately maintain and update appropriate quality control files and databases in a timely manner.
- Assist in maintenance of instrumentation and other laboratory equipment according to maintenance schedules and departmental procedures. Work with senior staff to initiate deviation reports for required discrepancies.
- Maintain supply levels for performance of assigned duties.
- Apply good laboratory practices as appropriate and assist or participate in problem solving as required.
- Maintain orderly, clean and safe workplace.
- Perform other quality control duties as assigned.
- Bachelor degree in Biology or a related scientific field with 1-3 years relevant experience in a FDA regulated environment. (or M.S. degree in a scientific field with 0-2 years relevant experience) or equivalent combination of education and experience with laboratory procedures, including but not limited to: serial dilutions, aseptic transfers, cell incubation/counting, plate reading and microscopy.
- Cell culture, tissue culture or molecular biology laboratory experience preferred.
- Accurate pipetting skills essential.
- Experience working with radioactive materials or laboratory samples a plus.
- Must be organized, show attention to detail and demonstrate good documentation practices.
- Good communication skills, both written and oral.
- Must have mathematical aptitude for performing data calculations. Basic knowledge and experience with Microsoft Excel, Access and Word programs.
- Demonstrates ability to learn new tasks and techniques.
- Some experience troubleshooting and/or problem solving.
- You are a team player. You take your work very seriously, but not always yourself.
- You are dedicated and reliable
- You are looking for an organization that values mission-driven, loyal individuals focused on achieving goals those in need of our services.
- You get things done
We offer a comprehensive benefit package for eligible team members including medical, dental, vision, short-term/long-term disability, life insurance, hospital indemnity and accident insurance. We also offer a generous retirement plan with a company match. Eligible employees also enjoy competitive time-off policies. We are a collaborative environment that promotes growth from within. Enjoy company-sponsored events for the entire team!
We can’t wait to work with you!
We are an equal opportunity employer.