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 and cell and gene therapies. 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 is responsible for the investigation and completion of process deviations aimed at identification of root cause, and implementation of correct actions to prevent recurrence.   Compliance specialist are expected to work in a cGMP environment, have working knowledge of mammalian or microbial manufacturing processes, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented, and be compliant minded while performing investigations

PRINCIPAL RESPONSIBLITIES:

  • Perform root cause analysis on manufacturing deviations, serving as primary author of deviation reports, utilize technical writing for the educated but uninformed reader, translate moderate to complex scientific events into a brief and cohesive report as a finished product.  Address comments from both internal and external stakeholders on the final report.
  • Lead investigations for manufacturing and bring them to a resolution with minimal direct supervision. Gather Data from various sources across the site, perform of Root Cause Analysis to determine the most likely cause of the deviation investigation, Assessment of event for impact to SISQP, Perform Trending Analysis, Identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, and Causing Mapping facilitation.
  • Initiate appropriate corrective action/preventative action (CAPA) to prevent deviation recurrence. Work closely with manufacturing operations, QA team, and support groups to develop appropriate CAPAs
  • Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward.  Conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objective.
  • Management of multiple projects and timelines concurrently.  Ability to adhere to standard timelines, and escalate actions appropriately for resolution in a timely manner. Participation in the Daily Management meetings to update leadership on current deviation statuses
  • Work with the manufacturing team by going to the production areas for data gathering, observing of processes for investigations, and performance of associate interviews.

KNOWLEDGE, SKILLS & ABILITIES:

  • Prior experience technical writing and in a manufacturing environment preferred
  • Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time event closure. Must work well on a team, and be able to trouble shoot and problem solve in a cross functional team setting.  Must be proactive, action 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 highly preferred
  • Minimum of 2+ years’ experience conducting investigation and root cause analysis in a pharmaceutical or FDA/GMP environment required
  • Experience with GMP compliance in clinical/commercial manufacturing environment required
  • Experience with quality management software (Mastercontrol, Trackwise, etc.) preferred
  • Experience with asset management software (Blue Mountain, Maximo, etc) preferred

 

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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