Quality Control Specialist

Company: AGC Biologics
Location: Longmont
Posted on: June 19, 2022

Job Description:

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.SummaryThe Quality Control Specialist performs complex and diverse laboratory activities in support of GMP testing and leads QC analytical method troubleshooting. A successful candidate will interact with staff internal and external to the Quality Control group within ACG Biologics. The staff may also communicate with clients external to AGC Biologics as a QC representative.Principal Responsibilities

• Perform routine testing such as flow cytometry, ELISAs, qPCR, ddPCR, and cell based assays in support of in-process, release, and stability
• Write, review, and perform method qualifications, transfers, and validations
• Own, author, and revise test methods and standard operating procedures as necessary.
• Lead troubleshooting for assays or procedures
• Work on advanced QC processes and issues that require understanding of company strategies, initiatives, expectations, processes, and customer commitments
• Develop and lead large programs, initiatives, and activities for the function and organization
• Contribute to development of best practices for functional area
• Analyze and evaluate issues and make decisions within general parameters under little supervision
• Communicate complex concepts and interact with others to inform and direct action
• Act as a resource in area of expertise
• Represent QC at internal and client team meetings as required
• Help drive processes and manage projects
• Quality is the responsibility of each employee at AGC. Each employee is expected to perform his/her tasks diligently and in compliance with requirements in AGC's Quality System
• Demonstrate a high level of compliance with company documentation practicesKnowledge, Skills & Abilities
  • Strong understanding of basic scientific concepts in multiple QC technical areas
  • Understanding of ICH guidelines, compendia, and regulations related to GMP production and testing of biologics
  • Experience with relevant analytical lab equipment and software
  • Ability to understand and analyze complex analytical/technical data
  • Ability to solve highly complex problems and can identify viable and innovative options
  • Excellent communication and interpersonal skills
  • Ability to interact constructively with coworkers and other departments
  • Excellent organizational skills, excellent attention to detail, and ability to multi-task
  • Working knowledge of MS Word, Excel and PowerPointEducation/Experience
    • BS/BA in Biology, Microbiology, or other science with at least 8 years of relevant experience
    • Equivalent education and experience may substitute for stated requirementsThe compensation range for this position is $78,803.00-$93,700.00 annually based on experience.AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances

Keywords: AGC Biologics, Longmont , Quality Control Specialist, Other , Longmont, Colorado