AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, on time. For more information, visit www.agcbio.com.

 

SUMMARY: The Manufacturing Compliance Specialist I is primarily responsible for management and completion of quality event investigations.  This position is an individual contributor role that works cross-functionally to collect information used to identify the root cause and mitigate recurrence.

 

PRINCIPAL RESPONSIBLITIES:

  • Perform root cause analysis on manufacturing quality events, serving as primary author of deviation reports
  • Utilize technical writing skills to a broad audience, translate moderate to complex scientific events into a brief and cohesive report as a finished product 
  • Facilitate and participate in meetings, aligning internal review team and area subject matter experts on an agreed upon investigational path forward
  • Lead investigations for manufacturing and bring them to a resolution with minimal direct supervision
  • Work with the manufacturing team by going to the production areas for data gathering, observing of processes for investigations, and performance of associate interviews
  • Address comments from both internal and external stakeholders on the final report
  • Gather data from various sources across the site
  • Assess event for impact to SISQP, perform trending analysis, perform Risk Assessments, and/or the use of problem solving tools (Flowcharts, 6M, Fishbone diagrams)
  • Work closely with manufacturing operations, QA team, MSAT, and support groups to develop appropriate actions and improvements
  • Initiate appropriate corrective action preventative action (CAPA) to prevent deviation recurrence
  • Participate in the management meetings to update leadership on current status of quality events

 

KNOWLEDGE, SKILLS & ABILITIES:

  • Ability to adhere to standard timelines, and escalate actions appropriately for resolution in a timely manner
  • Demonstrated skills in conflict resolution, problem solving in a cross functional setting, with the ability to keep the meeting on track to achieve objective
  • Prior technical writing experience within a manufacturing environment preferred
  • Must have the ability to work in a fast paced environment, with the ability to manage multiple projects and objectives for on-time event closure
  • Must work on a cross-functional team
  • Must be able to troubleshoot and problem solve
  • Must be proactive, detail-oriented, and have the ability to adapt to change
  • Must be able to identify and flag risks in a timely manner to keep deliverables on track
  • Strong written and verbal communication skills are required
  • Ability to read and comprehend complex subjects
  • Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems
  • Ability to understand and apply GMP regulations as they relate to manufacturing

 

EDUCATION/EXPERIENCE:

  • BS in scientific discipline such as Biochemistry, Chemistry, Biology or related discipline required
  • 2-4 year(s) experience in quality management systems, conducting investigations and/or root cause analysis working in a regulated or GMP environment required
  • Experience with GMP compliance in clinical/commercial manufacturing environment required
  • Experience with quality management system (MasterControl, Trackwise, etc.) preferred
  • Experience with asset management software (Blue Mountain, Maximo, etc) preferred
  • Equivalent education and experience may substitute for stated requirements

 

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.

 

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