Associate, Product Development Quality

Role Summary

Purpose: This role is primarily responsible for supporting AbbVie’s pipeline, by supporting batch disposition activities and ensuring high-quality clinical supplies that are compliant with global regulatory requirements and standards are delivered to patients. This is achieved by effectively partnering with the business, ensuring risks are mitigated appropriately and supporting efficient review of clinical supply batches to support continued uninterrupted access to clinical supplies. The successful candidate will manage multiple tasks and adjust priorities based on supply needs, interact with multiple functional areas, and resolve batch record documentation issues to maintain schedules and material availability.

Responsibilities

• Review and approve batch records and release batches or analytical records.
• Write/review/approve exception documents and product complaints (as applicable) corrective actions/preventive actions (CA/PA) and ensure they meet timeliness requirements.
• Assist in the preparation of audits conducted by regulatory agencies, customers, and GxP Compliance.
• Provide quality approvals in materials management system as defined by procedures.
• Write and/or review policies/processes/procedures and related documents.
• Actively participate on assigned project team(s) to support the product development process and timelines by using expertise to anticipate/resolve quality issues.
• Generate and report quality metrics to management.
• Participate with support groups in developing/prioritizing QA activity timelines.
• Actively monitor the effectiveness of processes and quality of project work with management and propose and execute quality/process improvements.
• Provide quality oversight on the manufacturing floor, as needed

Qualifications

• Bachelor's (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
• 2+ years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree.
• Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide -global requirements for GMP (D, EU, US) is preferred.
• Experience in coordination and planning activities
• Demonstrated organizational skills.
• Interpersonal and team negotiation skills to handle multiple priorities.
• Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues.
• Ability to identify and resolve quality issues through effective use of technical and interpersonal skills.

Additional Requirements

• Work in a clean room environment