Biopharma Exception Report Investigation Author

Location

Worcester, MA | United States

Job description

Are you looking for a challenging and rewarding opportunity in the field of Biopharma Investigation? Look no further! We are seeking a highly motivated candidate to join our team as the Biopharma Investigation Author.

As the Biopharma Investigation Author, you will be responsible for writing and project managing all Exception Reports and subordinate tasks/quality events (correction tasks, preventive actions and/or other nonconformity investigation report requirements) in a factual, clear, coherent, concise, complete, and compliant manner. Proactively manages the life cycle of investigation events to support ~30-day closure of routine investigations and other KPI-based timeline requirements. Chairs coordination meetings and manages deliverable timelines. Applies critical thinking and decision-making process to ensure that root cause analysis is performed and resulting corrective/preventive actions are systematically developed to ensure recurrences prevented. Ensures adherence to investigation timeframes and milestones, regulatory expectations, and AbbVie policies. 

If you thrive in a fast-paced environment, enjoy problem-solving, and have a passion for writing and project management, this is the perfect opportunity for you. Join our team and contribute to the world of Biopharma Investigation. Apply now!

Responsibilities:

• 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. Provide guidance on documentation content and requirements in support of investigations. Assign actions to cross functional meeting participants supporting the investigation process and assign deliverable timelines, accordingly.
• Write and review investigation reports using a technical narrative based on process science and technical knowledge that supports the identified root cause or most probable cause.
• Advise 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.). Apply critical thinking to discern relevant information to the investigation report.
• Design CAPAs aligned to root cause that are effective in preventing recurrences. Assign CAPA with reasonable timeframes, track due dates, review closing evidence, and approve closure.
• Ensure that investigation process adheres to timelines to ensure approval for routine events within 30 calendar days. Recommend data-supported improvement processed for the reduction of error events and/or design of effective CAPAs.
• Comply with all AbbVie policies, site procedures, regulatory agency requirements, Safety, and environmental regulations.

• Bachelor's degree in Chemistry, Biology, Microbiology, Engineering, or related technical/life sciences area preferred.
• A minimum of five (5) years of experience writing and/or reviewing and approving investigations including designing/approving CAPAs and/or commensurate technical writing experience.
• Experience in pharmaceutical/biotechnology operations, Quality Assurance, or technical/manufacturing support 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.
• Demonstrated superior oral and written communication skills, interpersonal skills, sense of urgency, ability to influence peers and management without authority.
• 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; basic small to medium-sized project/timeline management to comply with investigation and deliverable due dates.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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