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
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