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Quality Control Analyst Iii, Cell Therapy, 2Nd Shift

Expired Job

Lonza, Inc. Houston , TX 77020

Posted 4 days ago

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success.

Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. Our vision: We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission: We work with passion, using advanced technologies, to transform life science into new possibilities for our customers. Do you want to help us as we shape the future of this great organization?

Job Description Summary Job Summary Performs Quality Control assays for product release of cell therapy products, Raw Material Release and Stability Studies. Maintain data and follow cGMP regulations including writing deviations and other Quality documentation. Skill set includes (but is not limited to) PCR, Q-PCR, ELISA, cell count, and flow cytometry.

Job Description Performs Quality Control (QC) biological/cell based testing of Cell Therapy release and stability samples. Typical test methods performed include flow cytometry, proliferation, ELISA, cell counts (manual and automated), and immunofluorescence microscopy/spectroscopy. Write original and revise current SOPs, Forms and Test Records.

Writes edits and approves Deviations and CAPAs as required. Responsible for initiating Change Controls and completing necessary documentation. Participates in Cell Therapy technology transfer activities and validation of analytical methods including training on new methodology, setup of new equipment, generation of method standard operating procedures (SOPs), and execution of validation protocols.

Initiates Out of Specification (OOS), Cell Review Committee (CRC), and deviation Investigations as needed to address non-conformance's in the lab. Orders supplies and reagents. Performs general lab and equipment maintenance duties.

Essential Job Functions 2nd Shift (evening) Adhere to Good Documentation Practices. Maintenance of quality systems and cGMP compliance for the business by complying with processes, procedures and instructions for all activities in which the individual participates. A majority of the work is done in a laboratory environment.

While working in the laboratory a lab coat is required along with appropriate safety equipment as denoted for the designated area. The remaining work is done in an office environment with use of a personal computer or meetings held in a conference room setting. Must be able to lift up to 30lbs Attention to detail is critical for this position Minimum Required Qualifications and Skills BA or BS in a biomedical field.

Preferred area of study: Cell Biology 6+ years relevant experience in a biotech/pharmaceutical setting, 8+ years in an academic laboratory setting may also qualify. OR, MS in related field and 4+ years relevant experience in a biotech/pharmaceutical setting, 6+ years in an academic setting may also qualify.

Should have knowledge of cGMP facilities and cGMP requirements. Must have an advanced knowledge of Microsoft applications, especially Word and Excel. Other computer software skills including SAP, Trackwise, Documentum, LIMS, and SysAid are a plus.

Knowledge of basic and specialized laboratory equipment including biosafety cabinets, Flow cytometer and bioanalyzer is a plus. Must have good mathematics, scientific and good documentation skills. Previous experience in cell culture and aseptic technique preferred.

Knowledge of biology, chemistry, technical writing. Knowledge of cGMP (Biotech/Pharmaceutical industry) Knowledge of basic and specialized laboratory equipment including biosafety cabinets, centrifuges, spectrophotometers, incubators, fluorescent and phase contrast/bright field microscopes, plate reader and microphotography equipment is a plus Must be detail-oriented and have a right first-time attitude. Must be able to clearly communicate problems and observations with management from other departments.

Should work well in a team environment but have independent work skills and a strong work ethic. Able to clearly communicate problems and observations with management from other departments, and may be required to discuss technical issues directly with clients. Demonstrated skills in problem-solving and providing solutions.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. Lonza. The place to Go, Stay and Grow.



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VIEW JOBS 6/23/2018 12:00:00 AM 2018-09-21T00:00 At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. Our vision: We strive to be the leading supplier using science and technology to improve the quality of life. Our mission: We work with passion, using advanced technologies, to transform life science into new possibilities for our customers. Do you want to help us as we shape the future of this great organization? Job Description Summary Responsible for overseeing the performance of Quality Control assays for product release of cell therapy products, Raw Material Release and Stability Studies. Maintain data and follow cGMP regulations including writing deviations and other Quality documentation. Skill set includes (but is not limited to) PCR, Q-PCR, ELISA, cell count, and flow cytometry. Supervises a team of QC Analysts and coordinates day-to-day activities. Performs and oversees Quality Control (QC) biological/cell based testing of Cell Therapy release and stability samples. Typical test methods performed include flow cytometry, proliferation, ELISA, cell counts (manual and automated), and immunofluorescence microscopy/spectroscopy. Write original and revise current SOPs, Forms and Test Records. Writes edits and approves Deviations and CAPAs as required. Responsible for initiating Change Controls and completing necessary documentation. Responsible for day-to-day scheduling of QC analytical testing activities. Responsible for enabling career development of direct reports. Responsible for approval of time cards and Replicon entries of direct reports. Enable and maintain high-functioning team dynamics. Participates in Cell Therapy technology assay qualification activities and validation of analytical methods including training on new methodology, setup of new equipment, generation of method standard operating procedures (SOPs), and execution of validation protocols. Initiates Out of Specification (OOS), Cell Review Committee (CRC), and deviation investigations as needed to address non-conformances in the lab. Minimum Required Qualifications/Skills Education BA or BS in a biomedical field Preferred area of study: Cell Biology Experience 9+ years relevant experience in a biotech/pharmaceutical setting, 11+ years in an academic laboratory setting may also qualify. OR, MS in related field and 7+ years relevant experience in a biotech/pharmaceutical setting, 9+ years in an academic setting may also qualify. 2+ years supervisory experience preferred. Knowledge Should have knowledge of cGMP facilities and cGMP requirements. Must have an advanced knowledge of Microsoft applications, especially Word and Excel. Other computer software skills including SAP, Trackwise, Documentum, LIMS, and SysAid are a plus. Knowledge of basic and specialized laboratory equipment including biosafety cabinets, Flow cytometer and bioanalyzer is a plus. Skills Must have good mathematics, scientific and good documentation skills. Previous experience in cell culture and aseptic technique preferred. Knowledge of biology, chemistry, technical writing. Knowledge of cGMP (Biotech/Pharmaceutical industry) Knowledge of basic and specialized laboratory equipment including biosafety cabinets, centrifuges, spectrophotometers, incubators, fluorescent and phase contrast/bright field microscopes, plate reader and microphotography equipment is a plus. Qualities and Attitude Must be detail-oriented and have a “right first-time” attitude. Must be able to clearly communicate problems and observations with management from other departments. Should work well in a team environment but have independent work skills and a strong work ethic. Able to clearly communicate problems and observations with management from other departments, and may be required to discuss technical issues directly with clients. Demonstrated skills in problem-solving and providing solutions. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. Lonza. The place to Go, Stay and Grow. Lonza, Inc. Houston TX

Quality Control Analyst Iii, Cell Therapy, 2Nd Shift

Expired Job

Lonza, Inc.