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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.
The Sr Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
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.