Quality Control Associate I

Our purpose is to bring hope to life by enabling lifechanging therapies for patients around the globe creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients lives by bringing new biopharmaceuticals to market.

One Colorado one team. At our Boulder and Longmont locations we cultivate a unified team under the banner of One Colorado fostering collaboration among diverse teams and their respective business units. Together we leverage a shared services objective between the two sites to enhance care for our clients and their patients.

The Quality Control Associate I Microbiology 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.

RESPONSIBILITIES

• Complete microbiology and environmental monitoring assays including bioburden endotoxin conductivity and total organic carbon (TOC).

• Perform sampling of water for injection air clean steam compressed gas and facility surfaces in ISO classified manufacturing spaces.

• Support projects / initiatives / team goals by delivering on all assigned tasks.

• Perform data verification and data entry.

• Seeks opportunities for continual learning and improvement.

• Participate in test method transfers and assay validations.

• Support onboarding and qualification of laboratory equipment and GMP software systems.

• Assist with the generation of SOPs related to test methods and product release.

• 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 applicable reports.

• Serve as a trainer for Junior Analysts

• Serve as a Subject Matter Expert on a particular method program or discipline

KNOWLEDGE SKILLS AND ABILITIES

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required.

• Requires knowledge of environmental and utility monitoring programs compendial microbiological testing (Bioburden Endotoxin) and testing of purified water clean steam and water for injection.

• Experience working in a GMP laboratory.

• Strong organizational skills in a highthroughput environment.

• Excellent communication with clear and concise writing & verbal presentation skills.

• Ability to interact well in a team environment.

• Demonstrated organizational skills and attention to detail.

• Ability to lift 50 lbs. Ability to work long hours with physically demanding work wearing appropriate cleanroom garments and in utility support grey space areas.

EDUCATION and/or EXPERIENCE

• Education: Minimum BA in Biology Microbiology or other scientific discipline.

• 02 years of Laboratory and/or GMP experience

• Strong understanding of Microbiology related to drug substance or drug product manufacturing.

• Experience with relevant analytical laboratory equipment and software.

SCHEDULE

Wednesday through Saturday (4 10 hour) Day Shift position.

COMPENSATION

$23.31 $32.05 an hour

Our culture at AGC Biologics is defined by the six core values: Knowledge Trust Quality Ingenuity Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

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 sidebyside with our clients and partners every step of the way. We provide worldclass development and manufacture of mammalian and microbialbased 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 cGMPcompliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fasttrack projects and rare diseases. AGC Biologics is the partner of choice. To learn more visit.Want to keep posted about our growth and learn more about our company Follow us on LinkedIn and give us a quick Like on Facebook!

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.