Associate, Product Development Quality

Company Description

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Purpose:

This role is primarily responsible for supporting Abb Vie’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 be able to manage multiple tasks and adjust priorities based on supply needs. This position requires the ability to positively interact with multiple functional areas quickly and effectively resolve batch record documentation related issues, ensuring schedules are maintained and material is readily available.

• 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.

• Work in a clean room environment.

• 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.

• 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.

Note:

No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only – to learn more, visit

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