Quality Control Associate I

Our purpose is to bring hope to life by enabling life-changing 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.

This may be a Wednesday through Saturday (4- 10 hour) Day Shift, position.

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 high-throughput 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.

• 0-2 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.

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 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.  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.