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Quality Control Analyst III

Company: Revance
Location: Newark
Posted on: June 22, 2022

Job Description:

Position Summary:The QC Analyst III will support product testing (release, stability, and in-process samples) for both clinical and commercial activities within the Quality Control environment including analytical and cell-based assays. Author phase appropriate protocols and reports for transfer and validation of test methods including execution and establishment of test methods within Quality Control. Review laboratory documentation for accuracy, participate with the team to meet group goals and perform routine laboratory duties. Author quality records such as laboratory investigations, deviations and CAPAs. Participate in the preparation of investigations, summaries and reports as needed. Essential Functions:--- Perform routine and non-routine release, stability, and in-process sample testing and documentation under cGMP. --- Perform cell-based potency assays release and stability testing under cGMP including management of the cell bank. --- Conduct phase-appropriate method validation including authoring of protocols and reports. --- Review laboratory records generated in support of QC testing including procedures, methods, audit trails and other controlled documents --- Author quality records such as laboratory investigations, deviations, CAPAs and change controls, including leading thorough and timely investigation and/or implementation activities. --- Maintain laboratory space to regulatory expectations and internal procedures on a regular basis including support of equipment qualification and onsite vendor support. --- Provide training to laboratory analysts, as needed. Guide junior analysts in the laboratory environment including troubleshooting. --- Work collaboratively with Manufacturing, QA and Regulatory to support CMC analytical deliverables.Preferred Experience:--- A minimum 4 years work experience within a GMP environment working with peptides and proteins. --- Experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot. --- Experience with cell-based methods and aseptic technique. --- Technical training and troubleshooting experiences are preferred. --- Experience in performing data audit trail review and a strong understanding of data integrity principles within a GMP environment.Preferred Education:--- Requires a Bachelor of Science in Biochemistry, Biology or a related pharmaceutical-biotechnology discipline. Master of Science in related field is highly desired.Preferred Additional Skills:--- Knowledge of cGMP requirements and ICH guidelines. --- Excellent interpersonal and communication skills in a team-oriented environment are required. --- Strong critical thinking and problem-solving skills. --- Ability to work independently as well as within a team, handle multiple projects, demonstrate initiative and accountability, and strong attention to detail. --- Proficient written and verbal communication skills are required. --- Proficient in the use of Microsoft Word and Excel --- Experience with statistical software such as JMPWORK ENVIRONMENT & PHYSICAL DEMANDSThis section of the job description is required by the American with Disability Act, (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."

  • Prolonged periods of sitting at a desk and working on a computer
  • Must be able to lift up to 10 pounds at times We are an equal opportunity employer. We are a company where diverse backgrounds, experiences and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual's race, color, national or ethnic origin, religion, age, sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.

Keywords: Revance, Newark , Quality Control Analyst III, Professions , Newark, California

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