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- Review of executed manufacturing batch records for completeness, compliance, and accuracy to support product lot disposition.
- Review and approve logbook activities.
- Approve equipment and room change-over operations.
- Approve and execute area change-over operations.
- Support review and approval of Master Production Records (MPRs).
- Conduct review and approval of GMP documents (i.e. Standard Operating Procedures (SOPs), Forms, Work Instructions, etc.) in the electronic Document Management System.
- Support Deviations, CAPAs and Change Control, when required.
- Collaborate in the resolution of issues associated with the manufacturing operations, with the QA point-of-contact, to provide guidance and facilitate the resumption of manufacturing activities post deviation detection.
- This position is a Night Shift and will require to work 12-hour shifts to support Manufacturing, Quality Control, and Engineering Operations activities.
- Technical and analytical understanding of Biologics Manufacturing and testing.
- Knowledge of regulatory compliance principles, strategy, and rational as they relate to Biologics Manufacturing.
- Good oral and written communication skills.
- Good organizational skills.
- Demonstrated experience in areas of teamwork and problem-solving.
- Ability to work on moderately complex problems where analysis of situations or data requires an evaluation of factors.
- Understanding of basic scientific/technical concepts
- Bachelor's degree in Biology, Chemistry or other relevant science/engineering discipline or equivalent work experience.
- Previous experience in QA or related document control experience, as required below:
- Associate II - Minimum 2 years
- Associate III - Minimum 5 years
- Equivalent education and experience may substitute for stated requirements
Quality Assurance Associate, II - Boulder, United States - AGC Biologics
Description
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 Assurance Associate II-III (In Plant Operations) is responsible for providing (24/7/365) Quality support to the activities listed below at the Boulder, CO site.
RESPONSIBILITIES
Oversee Manufacturing floor operations and provide quality oversight. Specific Job Responsibilities include but are not limited to:
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.
$74,960 - $103,070
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 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.