What are the responsibilities and job description for the Technician, QA Manufacturing Support position at AGC Biologics A/S?
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.
QA Manufacturing Support Technician
AGC Biologics is looking for the QA Manufacturing Support Technician, who will be responsible for quality activities supporting Manufacturing Batch Release process in accordance with procedures and GMP requirements. Functional responsibilities include ensuring review of Batch Records in compliance with applicable procedures, providing real time review of manufacturing records and logbooks.
Primary Role (daily responsibilities):
- Support manufacturing during Batch Production Records (BPR) review with Good Documentation Practice related queries.
- Buffer and Media BPR review and approval.
- Batch Process Record print.
- Manufacturing label management.
Perform other duties as assigned (if necessary):
- Scanning.
- Archiving.
Qualifications and Experience:
Our preferred candidate has the following profile:
- Hold Bachelor (BSc) or degree as Laboratory Technician.
- Preferably have experience from a GMP production environment or QA department within the biopharmaceutical industry.
- Show interest or have previous experience in reviewing Batch Production Records (BPRs) and Solution Preparation Sheets.
- Have excellent collaboration and communication skills.
- Fluency in written and spoken English.
- Excellent written and verbal communication skills with internal and external stakeholders.
As a person, you have a positive mind, are flexible and enjoys taking on new tasks and responsibilities. You thrive in a dynamic environment and can cope with uncertainties.
We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible.
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.
