Associate Specialist, Quality Systems

AbbVie; Illinois; On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

PTO/Time off

Health insurance

401(k)

Job summary

AbbVie seeks an Associate Specialist Quality Systems to provide quality assurance support across manufacturing processes, ensuring compliance with corporate and governmental regulations. The role covers document control, device QA, labeling, validation, training and CAPA. Collaboration with project teams to review quality docs is essential.

The candidate should have a technical degree and 0-2 years in QA, with strong communication and interpersonal skills to deliver tactical quality outcomes.

Qualifications

• Bachelor’s Degree in a technical/scientific field; experience preferred.
• 0-2 years’ experience in quality assurance or related area.
• Knowledge of pharmaceutical, biologics, medical device quality systems preferred.
• Strong oral and written communication skills.
• Excellent interpersonal skills a plus.
• Delivers tactical results to support the quality system.

Responsibilities

• Provide QA support for manufacturing processes including drug, biologics, device or combination products.
• Review quality system changes and specifications for products.
• Process change requests creation, maintenance and implementation.
• Support project teams with quality documentation activities.
• Collect and compile key quality metric data.
• Participate in training and education programs for QA aspects.

Skills

Communication

Interpersonal skills

Quality mindset

Documentation/records

Education

Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or related technical field

0-2 years QA/quality oversight experience

Job 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 www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

The Associate 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.

Responsibilities

• Assist with proper integration and support of quality regulations: drug, biologics, device and/or combination products.
• Perform quality review of quality system and computerized system changes.
• Perform quality review of specifications associated with drug, biologics, device and/or combination products.
• Complete and route change requests for process document creation, maintenance, and implementation.
• Support project teams in planning, preparation, review and approval of quality documentation.
• Collect and compile key quality metric data.

• Participate in training and education programs for various aspects of quality assurance.

Qualifications

• Bachelor’s Degree (Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred) or equivalent experience.
• 0-2 years’ experience in quality assurance, quality oversight or relevant experience.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological and medical device products preferred.
• Strong oral and written communication skills needed.
• Excellent interpersonal skills a plus.
• Delivers tactical results to support the quality system.

Compensation and Benefits

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 employer 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html