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SalaryAbout AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.
SUMMARY:
The Quality Control Associate II 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, liquid chromatography, and capillary electrophoresis 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
- Collaborate on 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 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
- 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 practices
KNOWLEDGE, 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 PowerPoint
EDUCATION/EXPERIENCE:
- BS/BA in Biology, Microbiology, or other science with at least 2-4 years of relevant experience
- Equivalent education and experience may substitute for stated requirements
COMPENSATION RANGE:
$28.73 - $39.50
Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.
Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.
Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance.
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.
