Quality Systems Associate Specialist

Regulatory Toolkit; Chicago (IL); In loco; USD 90.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Paid time off

Medical/dental/vision insurance

401(k)

Descrizione del lavoro

AbbVie seeks a Quality Systems Associate Specialist to provide QA support across drug, biologics, device and combination products. You will help manage documentation, audits, CAPA, training and regulatory compliance from raw material inspection through final shipment.

Ideal candidates have a Bachelor's in a technical field and 3+ years in QA, with strong written and verbal communication and the ability to work both independently and in cross-functional teams.

Competenze

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
• 3+ years’ experience in quality assurance, quality oversight or relevant experience.
• Technical knowledge in QA, Regulatory, Process Sciences, Manufacturing Operations is preferred.
• Knowledge of QA systems and GMP compliance requirements for device, biologics, and pharmaceutical products.

Mansioni

• Assist with proper integration and support of quality regulations for drug, biologics, device, and/or combination products.
• Assist project teams in planning, preparation, review and approval of quality documentation.
• Complete and route change requests for process document creation, maintenance, and implementation.
• Create quality system documentation and specifications with guidance from technical teams.
• Assist with or co-lead audits of documentation, facilities and equipment.
• Contribute to design of effective quality systems, procedures and processes within cross-functional teams.
• Perform assessments to determine compliance and identify gaps for improvements.
• Participate in training and education programs for quality assurance.

Conoscenze

Quality, Regulatory, Process Sciences,

Strong communication skills

Project coordination

Team collaboration

Formazione

Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering

Descrizione del lavoro

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.

Purpose

The Quality Systems Associate Specialist 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.
• Assist project teams in planning, preparation, review and approval of quality documentation.
• Complete and route change requests for process document creation, maintenance, and implementation.
• Create quality system documentation and specifications with guidance from technical teams following approved templates and guidelines.
• Assist with or co-lead audits of documentation, facilities and equipment.
• Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.
• Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
• Participate in training and education programs for various aspects of quality assurance.

Qualifications

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
• 3+ years’ experience in quality assurance, quality oversight or relevant experience.
• Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products preferred.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.
• Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
• Strong oral and written communication skills needed.
• Excellent interpersonal skills a plus.
• Runs small projects to deliver tactical results.

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,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin 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 toparticipatein 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 bemodifiedat 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.

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