Research Triangle Park, North Carolina
The Investigator I is responsible for leading the investigation and documentation of deviations at FDBU, with minimal supervision. They are responsible for ensuring deviation timelines are met. The individual demonstrates a practical understanding of their areas’ processes and procedures, and applies their knowledge of cGDPs and cGMPs to investigate and document deviation root cause and compliance impact. The individual will be responsible for tracking performance metrics and analyzing them to identify trends and opportunities for improvement. They will provide periodic updates to internal and external Process Teams, Manufacturing, Quality, and Regulatory Agencies.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Investigate and document deviations and events, working with different functions and areas to identify impact and close PRs within the required standard work timeline
- Apply Site and Global compliance SOPs to investigations
- Identify and address corrective and preventative actions (CAPAs) based on root cause analysis and ensure they are implemented and effective
- Organize, participate in and/or lead cross-functional investigational teams including internal and external (client) members
- Track and analyze performance metrics to identify trends and develop continuous improvement projects
- Participate in Problem Analysis (PA) sessions
- Support document revisions, review/ approval of investigation records and participate in quality improvement initiatives
- Prepare storyboards for significant events and/or issues
- Participate and/or lead difficult discussions to internal team, clients and regulatory agencies
- Attend and participate in meetings, including tier meeting, internal and external client calls, team huddles, business review meetings, and others as needed.
- Demonstrated knowledge of cGDPs and cGMPs and the requirements to operate in a clinical and commercial manufacturing environment
- Demonstrated understanding of their functional area, such as manufacturing, quality control, engineering, process development, analytical development and validation
- Ability to independently prioritize work based on program needs and deviation timelines
- Understanding of operational excellence and the ability to apply root cause analysis, problem solving and continuous improvement methodology
- Strong knowledge of Excel, Word, and PowerPoint
- Understanding of statistical concepts
- Ability to lead investigation teams, directing the work of others to support investigations and corrective/preventive actions
Oral & Written Communication
- Author/Review/Approve internal and external technical documents and SOPs
- Collaborates and communicates across work groups and project teams
- Authors and presents deviation summaries, metrics and improvement projects to internal and external leadership teams
- Participates in Problem Analysis sessions
- Direct communication with the client under the supervision of their Manager and/or Quality
This position reports to a manger or director in their designated area. It is an independent contributor position, with minimal supervision for day to day activities.
This position supports the successful completion of deviations, as well as the identification and implementation of corrective/preventative actions, within their organization. The individual is responsible for maintaining deviation timelines and escalating when they cannot be met.
This position requires a BS/BA and a preferred 6+ years’ experience or MS and a preferred 2+ years’ experience or PhD in science, engineering or other related field
The individual should have demonstrated proficiency in the following areas:
- Biopharmaceutical analytical development/support, process development and/or manufacturing experience
- Practical experience with cGDP and cGMP requirements
- Planning, execution and prioritization of work based on deadlines and business impact
- Ability to clearly escalate risks to programs and timelines
- Strong knowledge of Excel, Word, and PowerPoint
- Ability to work in a cross functional team environment
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.