What are the responsibilities and job description for the Quality Systems Associate I position at AGC Biologics, Inc.?
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
Assists with activities related to creating, implementing, and maintaining quality systems.
ESSENTIAL JOB DUTIES
Enter documents in eQMS as directed.
Review document metadata and properties configuration and report issues.
Issue records, logbooks, and labels based on procedures.
Assist with gathering data or creating Annual Product Reviews (APR) for GMP products manufactured upon disposition, in compliance with Client agreements.
Assist or perform document scans and archival activities.
Supports in preparation for audits (internal, external, inspections).
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.
TECHNICAL & LEADERSHIP SKILLS
Exchanges straightforward information, asks questions and checks for understanding.
Develops skills in communicating concepts and interacting with others.
EDUCATION & EXPERIENCE
BS/BA degree and 0-2 years of relevant experience. Equivalent education and experience may substitute for stated requirements.
SCHEDULE
Night Shift: Mon-Thu, 4:00pm-3:00am
COMPENSATION
$23.30 - $32.04
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.
Salary : $23 - $32
