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.
The Deviation Investigations Specialist I/II is primarily responsible for management and completion of site investigations. This position is an individual contributor role that works cross-functionally to collect information used to assess impact, identify root cause and mitigate recurrence through CAPAs.
- Manage cross-functional investigations in response to site deviations
- Own, lead, author and drive investigations to closure including:
- Information gathering
- Impact assessments
- Root cause analysis
- CAPA identification
- Facilitate and attend triage meetings to gather facts/data upon event discovery
- Facilitate and participate in meetings, aligning internal review team and area subject matter experts on an agreed upon investigational path forward
- Perform Risk Assessments
- Utilize RCA tools including flow charts, fishbone diagrams, 6Ms and 5 whys to identify Root Cause
- Utilize technical writing skills to communicate moderate to complex technical issues into a cohesive report as a finished product
- Serve as liaison between multiple teams including Manufacturing, MSAT, Engineering, Quality Control, Supply Chain and Quality Assurance.
- Metrics tracking and reporting
- Participate in management meetings to update leadership on current status of investigations
Deviation Investigations Specialist I:
- Lead Minor investigations and bring them to resolution with minimal direct supervision
- Support Major and Critical investigations
Deviation Investigations Specialist II:
- Lead Major and Minor investigations and bring them to resolution with minimal direct supervision
- Support Critical investigations
KNOWLEDGE, SKILLS & ABILITIES:
- Strong knowledge of GMP regulations and ability to apply them to commercial manufacturing
- Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint)
- Demonstrated skills in conflict resolution in a cross functional setting with the ability to keep the objectives on track
- 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 escalate 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
- BS in scientific discipline such as Biochemistry, Chemistry, Biology or related discipline
- Prior technical writing experience within a GMP manufacturing environment preferred
- Experience with quality management system (MasterControl, TrackWise, etc.) preferred
- Equivalent education and experience may substitute for stated requirements
Deviation Investigations Specialist I
- Minimum 2 years’ experience in quality management systems, conducting investigations and/or root cause analysis working in a regulated or GMP environment required
Deviation Investigations Specialist II
- Minimum 5 years’ experience in quality management systems, conducting investigations and/or root cause analysis working in a regulated or GMP environment required
$59,760-$103,070 annually, depending on level and experience
Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.
Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.
Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance.
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