Senior Associate, Product Development Quality Assurance-Hybrid, Chicago

AbbVie; North Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

Paid time off

401(k) plan

Job summary

AbbVie seeks a quality-focused professional to support clinical supplies and batch disposition activities, ensuring regulatory compliance and timely delivery to patients. You will partner across functions to mitigate risks and maintain schedules.

Responsibilities include reviewing batch records, leading audits, and driving continuous quality improvements on the manufacturing floor, with strong communication and organizational skills essential.

Qualifications

• Bachelor’s degree, typically in life sciences (biology, chemistry, or engineering), and/or equivalent experience.
• 4+ years in QA, production, or testing of APIs or drug products.
• Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and GMP requirements.
• Experience coordinating and planning complex activities.
• Proven organizational skills.
• Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities.
• Effective oral and written communication skills to convey quality positions clearly.
• Ability to identify and resolve complex problems through technical and interpersonal skills.

Responsibilities

• Review and approve batch records and release batches or analytical records.
• Lead/assist in audits conducted by regulatory agencies, customers, and R&D GxP Compliance.
• Provide quality approvals in the materials management system and write/approve exception documents and CAPAs.
• Review/approve clinical documentation and specifications.
• Lead/participate on project teams to anticipate and resolve quality issues.
• Generate, analyze, and report quality metrics to management.
• Monitor effectiveness of processes and propose quality improvements.
• Provide quality oversight on the manufacturing floor as needed.

Skills

Quality Assurance

GxP Compliance

Analytical thinking

Communication

Leadership

Problem solving

Education

Bachelor’s degree in Life Sciences

Job description

Company Description

• About AbbVie

AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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 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 independently, ensuring schedules are maintained and material is readily available.

Responsibilities

• Review and approve batch records and release batches or analytical records. Write/ review/ approve processes/procedures and related documents.
• Lead/assist in the preparation and management of audits conducted by regulatory agencies, customers, and R&D GxP Compliance.
• Provide quality approvals in the materials management system as defined by procedures. Write, review and/or approve exception documents and product complaints (as applicable), corrective actions/preventive actions (CA/PA) and ensure they meet timeliness requirements.
• Review/approve clinical documentation and specifications, as applicable.
• Actively lead/participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality issues.
• Generate, analyze, and report quality metrics to management. Lead/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 degree, typically in life sciences (biology, chemistry, or engineering), and/or equivalent experience.
• 4+ years of industry experience in Quality Assurance, production, or testing of active pharmaceutical ingredients, drug products, drug development, or another healthcare-related field; less experience may be considered with an advanced degree.
• Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide GMP requirements (D, EU, US) is preferred.
• Experience coordinating and planning complex activities.
• Proven organizational skills.
• Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities.
• Effective oral and written communication skills to clearly communicate the quality position and the actions necessary to resolve issues.
• Ability to identify and resolve complex problems through effective use of technical and interpersonal skills.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• 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.

AbbVie 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.