Senior Associate, Product Development Quality Assurance-Hybrid, Chicago

AbbVie; North Chicago (IL); Hybrid; USD 79,000 - 141,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie Inc. in Chicago seeks a Senior Associate, Product Development Quality Assurance to support batch disposition and ensure clinical supplies meet global regulatory standards.

The role partners with multiple functions to mitigate risk and review batch documentation for timely release. The successful candidate will manage multiple tasks, adapt to supply needs, and provide quality oversight on the manufacturing floor as needed.

Qualifications

• Bachelor’s degree in life sciences (biology, chemistry, or engineering) or equivalent.
• 4+ years of industry experience in Quality Assurance, production, or testing in healthcare fields.
• Broad understanding of pharmaceutical manufacturing processes (chemical and biological) and GMP (D, EU, US).
• Experience coordinating and planning complex activities.
• Proven organizational skills and ability to handle conflicting priorities.
• Strong written and oral communication to advocate for quality.
• Ability to identify and resolve complex problems using 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 materials management systems and manage CAPAs and deviations.
• Review/approve clinical documentation and specifications as applicable.
• Lead/participate on project teams to support product development and resolve quality issues.
• Generate and report quality metrics to management and assist in QA timelines.
• Monitor process effectiveness and drive quality improvements across projects.
• Provide quality oversight on the manufacturing floor when needed.

Skills

Quality Assurance

GMP knowledge

Audit coordination

Documentation & record review

Interpersonal leadership

Problem solving

Education

Bachelor’s degree in life sciences

Job description

Senior Associate, Product Development Quality Assurance-Hybrid, Chicago

• Full-time
• Salary Min: 78500
• Salary Max: 141000
• Workday Global Grade: 16
• Compensation: USD 78,500 - USD 141,000 - yearly

• 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.

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.

• 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.

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

The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified in thefuture.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

This job is eligible toparticipate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremains in the Company’ssoleandabsolutediscretion unless and until paid andmay bemodified at the Company’s sole and absolute discretion, consistent withapplicable 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.