Supervisor, Quality Assurance

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 Supervisor, Quality Assurance In-Plant position is responsible for the oversight of the day-to-day activities of the In-Plant Quality Operations team.  This position requires the ability to work under minimal direction, strong technical knowledge of manufacturing processes and quality regulations, the ability to work on complex problems, attention to detail, organization, and comfort interacting with personnel within all levels of the organization.  

One Colorado, one team. At our Boulder and Longmont locations, we cultivate a unified team under the banner of 'One Colorado', fostering collaboration among diverse teams and their respective business units. Together, we leverage a shared services objective between the two sites to enhance care for our clients and their patients.

SCHEDULE: Nights 18:00 - 02:30

KEY RESPONSIBILIES:

• Provide direct supervision to QA In-Plant team and supervises daily/weekly tasks
• Demonstrate strong understanding of, and compliance with, procedures to support GMP compliance
• Coordinate and/or review executed batch records and associated documents, product testing records, logbooks, work orders, etc. for completeness, compliance
• Review documentation supporting GMP operations
• Assist with investigations and resolution of manufacturing, equipment, or facilities related deviations
• Review and approve Minor deviations and CAPA, may review and approve Major deviations
• Partner with other departments/groups to address routine operational issues and escalate more complex issues
• Partner with other departments to proactively address GMP compliance concerns and resolve problems
• Represent QA in cross-functional project teams for relatively straight-forward projects with less challenging clients
• Provides technical leadership in a specific work area
• Prioritizes and assigns project goals; ensures tasks are completed and work area goals are met.
• Coordinates with other supervisors and teams to meet the business need and output requirements
• May coach team members on task and skill proficiency and performance with manager’s guidance
• Performance management and appraisals
• Other duties as assigned
   

KNOWLEDGE, SKILLS & ABILITIES:

• Strong verbal and written communications skills.
• Applies understanding of how the team relates to other related areas to improve efficiency of own team.
• Recognizes performance improvements and conveys feedback constructively.
• Outstanding customer service skills with the ability to work effectively with diverse groups at various levels within the company.
• Well organized, flexible, and responsive.
• Good judgement with strong interpersonal relationship, team building, and collaboration skills
   

 EDUCATION/EXPERIENCE:

• BS/BA degree with 5+ years of industry experience, or Master’s degree with 3+ years of industry experience. Equivalent education and experience may substitute for stated requirements. 
• Previous managerial experience preferred, but not required.  
• Prior experience with biologics manufacturing preferred.
• Ability to understand and apply GMP regulations as they relate to manufacturing, test laboratory and facility operations.

Compensation Range:

$83,920 - $115,390 based on experienced 

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.