Quality Control Associate II - Microbiology
Company: AGC Biologics
Posted on: June 14, 2022
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. 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
We are currently looking for a Quality Control Associate II -
Microbiology to join the AGC Biologics team. This position will
focus on performing microbial and environmental monitoring assays,
facility qualification, and testing of purified water and cleaning
samples. This position may also review data, execute validation
studies, and support commissioning of laboratory instruments. The
ideal candidate will be highly motivated, organized, and have the
ability to work independently. Experience in a GMP Microbiology
laboratory is preferred. This may be a Sunday through Wednesday or
a Wednesday through Saturday (4- 10 hour) Day Shift, position.
- Complete microbiology and environmental monitoring assays,
including bioburden, endotoxin, conductivity and total organic
- Perform sampling of water for injection, air, clean steam,
compressed gas and facility surfaces in ISO classified
- Support projects / initiatives / team goals by delivering on
all assigned tasks.
- Perform data verification and data entry.
- Seeks opportunities for continual learning and
- Participate in test method transfers and assay
- Support onboarding and qualification of laboratory equipment
and GMP software systems.
- Assist with the generation of SOPs related to test methods and
- Assist in drafting technical documents including test methods,
validation documents, and deviations.
- Implement change controls, lead investigations, and complete
CAPAs in support of GMP operations.
- This position will support preparation of quarterly and annual
reports, trend investigations, statements of quality, and other
Knowledge, Skills & Abilities
- Requires knowledge of environmental and utility monitoring
programs, compendial microbiological testing (Bioburden, Endotoxin)
and testing of water for injection.
- Experience working in a GMP laboratory.
- Strong organizational skills in a high-throughput
- Excellent communication with clear and concise writing & verbal
- Ability to interact well in a team environment
- Demonstrated organizational skills and attention to
- Ability to lift 50 lbs.
- Ability to work long hours with physically demanding work,
wearing appropriate cleanroom garments and in utility support grey
- Education: Minimum BS in Biology, Microbiology, or other
- 3-5 years' Laboratory and/or GMP experience.
- Strong understanding of Microbiology related to drug substance
or drug product manufacturing.
- Experience with relevant analytical laboratory equipment and
$29.93 - $35.91 per hour
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
Keywords: AGC Biologics, Boulder , Quality Control Associate II - Microbiology, Other , Boulder, Colorado
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