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.

JOB SUMMARY: 

AGC Biologics is looking for a Quality Control Associate I to join the Quality Control Microbiology team. The Quality Control Associate I performs basic QC analysis and documents activities according to SOPs following good manufacturing processes (GMP) and demonstrates ability to learn QC methods, procedures, and systems. This associate will primarily focus on Environmental Monitoring and Microbial assays.  The ideal candidate will be highly motivated and self-driven with the ability to work independently. 

ESSENTIAL DUTIES/RESPONSIBILIES: 

• Facility Monitoring of non-viable air, viable air, surfaces and Utilities.

• Data generation, data entry, and data analysis.

• Performs laboratory-based work including testing of bioburden and endotoxin, microbial identification, total organic carbon, pH and conductivity. 

• Effectively communicate on a timely basis with management and team members.

• Seeks opportunities for continual learning.  

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

• Analyzes issues and makes decisions based on standardized processes and procedures under direct supervision.

• Seeks opportunities for continual learning.

• Receives close and regular instruction, guidance, and direction from others in the form of steps and tasks.

• Develops skills in communicating concepts and interacting with others.

SKILLS: 

• Exchanges straightforward information asks questions and checks for understanding. 

• Develops skills in communicating concepts and interacting with others. 

QUALIFICATIONS:

Required:

• ​​BS/BA degree in Microbiology or related field,  and 0- 2 years relevant experience in a QC environment. Equivalent education and experience may substitute for stated requirements.

• GxP knowledge.

• Possesses benchtop microbiology skills and aseptic techniques. 

• Knowledge and proficiency with Microsoft Office.

Preferred:

• Knowledge and experience in cGMP and the regulatory requirement for pharmaceuticals.

Physical Requirements:

• Ability to gown into a classified cleanroom environment, including aseptic spaces of ISO 5 and 6 classification. 

• Ability to stand, reach, bend, twist, squat, and move freely in a controlled environment while gowned.

COMPENSATION:  ​

$23.31 - $32.05/Hour​ 

SCHEDULE:

This position works Sunday - Thursday, 3:00pm-12:00am and is eligible for a 10% shift differential.

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.