Quality Systems Specialist

BioSpace; Mettawa (IL); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Paid time off

Medical/Dental/Vision insurance

401(k) participation

Job summary

A leading pharmaceutical company in Mettawa is seeking a Quality Systems Specialist to provide quality assurance support for various manufacturing processes. The ideal candidate will have a Bachelor's degree in a related field and over 3 years of quality assurance experience. Responsibilities include assisting in audits and creating documentation to ensure compliance with regulations. This role offers competitive compensation and benefits.

Qualifications

• 3+ years experience in quality assurance or relevant experience.
• Technical knowledge in Quality, Regulatory, and Manufacturing Operations.
• Experience running small projects.
• Ability to work in teams and manage time independently.
• Strong written and verbal communication skills.

Responsibilities

• Assist with quality regulations for pharmaceutical products.
• Create quality system documentation with guidance.
• Perform assessments to determine compliance.
• Create quality system documentation with guidance from teams.
• Assist or co-lead audits of documentation, facilities and equipment.
• Design effective quality systems and procedures with cross-functional teams.
• Perform assessments to ensure compliance and identify gaps.
• Participate in training programs for QA.

Skills

Quality Assurance

Communication Skills

Interpersonal Skills

Project management

Communication

Education

Bachelors Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering

Tools

GMP Compliance

Job description

Join to apply for the Quality Systems Specialist role at BioSpace

Company Description: 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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose

The Quality Systems 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

• Bachelors 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.

Additional Information

• 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.
• This job is eligible to participate in our long-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.

US & Puerto Rico only - to learn more, visithttps://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