- 189558 - QC Scientist I
- St. Louis
- 5 mos
- Chipton-Ross is seeking a QC Scientist I for an opening in St. Louis, MO.
The QC Analytical Scientist’s primary responsibility is to perform routine to complex QC testing pertaining ELISA testing and Cell Based Assays in accordance with cGMP regulations and Thermo Fisher standards to meet departmental and organizational goals. This position entails testing for GMP release and stability along with support for the validation and qualification of ELISA and Cell Based Assays. Additional responsibilities include supporting the department to establish robust work processes and assess for continuous improvement opportunities.
Perform in-lab assay execution support for validation, qualification studies, and routine testing by ELISA and cell-based bioassays. Revise/review specifications, SOPs, and other documents regarding QC-Analytical testing and assay execution. Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance. Effectively communicate with peers, manufacturing, AD and QC staff, to resolve technical issues and direct activities. Provide support to site Safety initiatives. Perform any other tasks as requested by Senior Management to support Quality oversight activities.
2+ years of experience within the biopharmaceutical or pharmaceutical industry, preferably in ELISA or cell-based bioassay field. Extensive knowledge of GMP regulations in a cGMP manufacturing environment. Working Knowledge of scientific principles for wide range of analytical techniques strongly preferred. ELISA and Cell Based Assay experience with large molecules is strongly recommended. Routine use of MS Excel, MS PowerPoint, and MS Word is essential. 2 years of ELISA or Cell Based Assay Experience (must have GMP experience and a Bachelors degree).
Knowledge, Skills, Abilities
Ability to understand customer requirements related to Quality control, including processes and equipment. Outstanding technical writing skills. Highly organized with attention to detail. Ability to communicate clearly and professionally in writing and verbally. Flexibility in problem solving, providing direction and work hours to meet business objectives. Working knowledge in 5S, SAP, and Trackwise preferred.
Accredited Bachelor’s Degree in a Biological Science or related field.
1st Shift - M-F, 8:30-5:00
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.