Quality Systems Associate III/Senior

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 www.agcbio.com.   

 

SUMMARY:

The primary responsibilities for the QS Associate III/IV role include site ownership of Quality Systems; Deviations, Corrective and Preventive Action (CAPA), Change Control, Quality Management Review, etc. supporting commercial drug manufacturing sites.  Works on moderate to highly complex problems where analysis of situations or data requires an in-depth evaluation of various factors.  This role requires attention to detail, organizational skills, multi-tasking, leading meetings, and comfort interacting cross-functionally with senior level personnel and regulatory inspectors.   The successful candidate can work under minimal direction and possesses the ability to work on complex problems by analyzing procedures and data to create appropriate solutions.

PRINCIPAL RESPONSIBILITIES:

• Site subject matter expert on AGC Biologics Quality Systems (i.e Deviation, CAPA, Change Control) and electronic QMS.
• Provides training in deviation investigation and root cause analysis techniques and best practices.
• Provides training on change control processes.
• Monitors Quality Systems and reports metrics regarding the health of the systems.
• Leads and/or supports Change Control Review Board.
• Leads continuous improvement projects.
• Manages input into Annual Product Quality Review (APQR).
• Manages Site Quality Plan.
• Supports other Quality Systems (i.e. Training, Document Control), as needed.
• Supports Data Integrity initiatives, as needed.
• Support Complaints and Recalls, as needed.
• Maintains SOPs and other GMP documents as needed to support Quality System programs.
• Supports regulatory inspections as needed.
• May act as a delegate for other Quality System Associates (all levels) and for Director Quality Systems with respect to topics related to Quality Systems.

 

KNOWLEDGE, SKILLS & ABILITIES:

• Strong knowledge of GMP guidelines as well as international regulations pertaining to the production of APIs and drug products including, but not limited to, ICH Q7, ICH Q10, 21 CFR 210 and 211, 21 CFR Part 11, 21 CFR 600 and 610.
• Proven technical writing skills.
• Proven ability to conduct root cause analysis and risk assessments.
• Skill in verbal communications.  Ability to respond to complex inquiries or complaints from customers, co-workers and supervisors regarding products and processes.
• Strong knowledge of quality processes and compliance.
• Ability to independently determine and develop approaches to address simple to complex issues.
• Knowledge of and skill in using computer software and hardware applications.  Proficiency with Microsoft applications, including MS Word, MS Excel and Teams preferred.
• Skill in time and priority management.  Must be able to work under general direction to complete work tasks.
• Demonstrated ability to work collaboratively to accomplish deadlines and objectives.

 

EDUCATION/EXPERIENCE:

• Bachelor's degree (B.S.) or equivalent in chemistry, engineering or related life sciences field.
• Minimum 5 years prior working experience for a QS Assoc III and minimum 8 years prior working experience for a QS Assoc IV in a Biotech/Pharmaceutical production environment is required; preferably, with at least 3 years’ experience working with Deviations/Change Control.
• Experience interacting with FDA or other regulatory agencies strongly preferred.
• Experience with TrackWise or equivalent system preferred.

 

 

COMPENSATION RANGE:

$74,960- $115,390