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Quality Control Associate III - Boulder, United States - AGC
Description
Quality Control Associate III page is loadedQuality Control Associate III
Apply
locations
Boulder, Colorado, USA
time type
Full time
posted on
Posted Today
job requisition id
JR100387
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
The Quality Control Associate III - 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 the 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 (10 hours) Day Shift, position.
ESSENTIAL DUTIES AND 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
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 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
Minimum BS in Biology, Microbiology, or other scientific discipline
5 -10+ years of Laboratory and/or GMP experience
Strong understanding of Microbiology related to the drug substance or drug product manufacturing
Experience with relevant analytical laboratory equipment and software
COMPENSATION RANGE:
$74,960 to $103,070.00
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, visitW
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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.
About AGC Biologics
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.
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