Categories: Careers
Date: Jan 31, 2010
Title: Quality Control Analyst
Cytovance® Biologics, a biotechnology contract development and manufacturing company, is seeking a full time, permanent, Quality Control Analyst for our facility located in Oklahoma City, OK.
The Quality Control Analyst will be responsible for performing and documenting QC release testing of clinical manufacturing materials per SOP’s, in compliance with cGMP’s. Duties will be carried out in accordance with quality standards set by the company and applicable government agencies.
Duties and Responsibilities:
- Performing HPLC, spectrophotometric, electrophoretic ,and various other analytical chemistry techniques for biopharmaceutical protein products and raw materials to assure conformance to specification.
- Provide timely and complete data, data review and reporting of out of specification (OOS) results. Participate in OOS investigations.
- Analyze equipment swabs and rinse samples for residuals to monitor effectiveness of equipment cleans.
- Assist with the overall maintenance and calibration of the QC laboratory.
- Analyze laboratory data for trending.
- Draft and review SOP’s and documentation to support ongoing activities in the QC department.
- Other duties may be assigned.
Qualifications:
- Bachelor's degree (B. S.) in a biological science from a four-year college or university; experience in the biopharmaceutical industry preferred.
- Requires the ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, business correspondence, and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Able to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Able to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- BS preferred in chemistry or life science discipline, with 1-3 years relevant experience in a QC analytical laboratory environment.
- Experience with protein characterization testing—electrophoresis (SDS-PAGE, Western blots, IEF, CE) ELISA, spectrophotometric (protein conc.)
- A solid working knowledge of cGMP as it relates to the QC laboratory.
- Strong mathematical and statistical analysis skills.
To apply for this position, please submit your resume to careers@cytovance.com or send it via postal service to Human Resources, 840 Research Parkway, Suite 400, Oklahoma City, OK 73104.