Sr. Investigation Writer Leader (Temporary position)
AbbVie
- Barceloneta, PR
- Temporal
- Tiempo completo
- Lead/Participate in investigation forums such as initial triage, initial impact assessment, investigation strategy meetings, root cause and CAPAs alignment meetings.
- Identify support function required to support the investigation process. Provides guidance on documentation content and requirements in support of investigations. Assigns actions to cross functional meeting participants supporting the investigation process accordingly.
- Write/review/approve investigation reports using a technical narrative based on process science and scientific knowledge that supports the identified root cause or most probable cause.
- Train investigators and cross functional team members on the best practices to write investigation reports that are factual, clear, coherent, concise, complete, compliant.
- Apply 6-sigma principles to the investigation process to identify root cause or most probable cause (5-why, 6M, affinity diagrams, brainstorming, etc.). Applies critical thinking to discern relevant information to the investigation report.
- Design CAPAs aligned to root cause that are effective in preventing recurrences. Assign CA-PA with reasonable timeframes, track due dates, reviews closing evidence and approves closure.
- Ensure that investigation process adheres to timelines to ensure approval in 30 calendar days. Leads improvement process for the reduction of investigations and/or design of effective CAPAs.
- Approve investigations (initial impact assessment, investigation report) as delegated by manager.
- Responsible to comply with AbbVie Policies, site procedures, Regulatory Agencies and Safety & Environmental regulations.
- Assure fulfillment of Environmental, Health, and Safety (EHS) requirements and compliance obligations, promote continuous improvement, and consider EHS aspects during the design and change process.
- Bachelor's degree in Science. Master's degree preferred.
- A minimum of eight (8) years of experience writing and approving investigations including designing/approving CAPAs. A minimum of three (3) years of experience managing direct reports.
- Experience in pharmaceutical/biotechnology operations, QA or technical support is necessary to successfully perform responsibilities of the position.
- Advanced technical writing skills focused on writing investigation reports that are factual, clear, coherent, concise, complete, compliant.
- Ability to develop tools/training content and to deliver training to investigators and cross functional team members on investigation process, writing and CA-PA development.
- Demonstrated superior communication, interpersonal skills, sense of urgency, discern priorities, ability to influence peers and management.
- Excellent knowledge and application of Good Manufacturing Practices and regulatory expectations for investigations and corrective/preventive actions.
- Capable of handling multiple priorities and customer needs; able to get organized to comply with investigations due dates.
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.