ZipRecruiter

Log In

1

Trackwise Jobs in Chicago, IL (NOW HIRING)

Assertio Therapeutics

Manager, QA

Lake Forest, IL · On-site

Experience with Quality Management Systems (Trackwise, Veeva, etc.) is required * Experience with combination products a bonus Skills and Abilities * Strong oral and written communication skills

Assertio Therapeutics

Manager, QA

Lake Forest, IL

Experience with Quality Management Systems (Trackwise, Veeva, etc.) is required * Experience with combination products a bonus Skills and Abilities * Strong oral and written communication skills

Assertio Therapeutics

Manager, QA

Lake Forest, IL

Experience with Quality Management Systems (Trackwise, Veeva, etc.) is required * Experience with combination products a bonus Skills and Abilities * Strong oral and written communication skills

previous page

Showing results 21-34

All JobsTrackwise JobsTrackwise Jobs in Chicago, IL

Trackwise information

See Chicago, IL salary details

$5.1K

$9K

$13.8K

How much do trackwise jobs pay per month?

As of Aug 18, 2026, the average monthly pay for trackwise in Chicago, IL is $8,995.08, according to ZipRecruiter salary data. Most workers in this role earn between $5,366.67 and $12,616.67 per month, depending on experience, location, and employer.

What is a Trackwise?

A TrackWise job typically involves working with TrackWise, a quality management system (QMS) used in regulated industries like pharmaceuticals, medical devices, and biotechnology. Professionals in these roles manage and configure TrackWise to streamline quality processes such as deviations, CAPA, audits, and complaints. Responsibilities may include system administration, troubleshooting, validation, and ensuring compliance with regulatory standards. Strong knowledge of TrackWise configuration, workflows, and reporting is often required.

What does a Trackwise specialist do?

As a TrackWise Specialist, your typical day involves configuring and maintaining the TrackWise quality management system, resolving user issues, and supporting key functions such as CAPA, document management, and audit tracking. You will regularly collaborate with quality assurance, IT, and operations teams to ensure system alignment with company processes and regulatory requirements. Additionally, you may train end-users, generate reports, and participate in system upgrades or process improvement initiatives. This role requires strong attention to detail and excellent communication skills to ensure accurate data management and continuous quality improvement.

What are the key skills and qualifications needed to thrive in the Trackwise position?

To thrive as a TrackWise Specialist, you need a strong foundation in quality management systems (QMS), regulatory compliance knowledge, and experience in data analysis, typically supported by a degree in life sciences, engineering, or a related field. Proficiency in the TrackWise QMS software, as well as familiarity with document control, CAPA, and audit management modules, is essential, and TrackWise certification is highly regarded. Strong problem-solving, attention to detail, and effective communication skills are key soft skills for collaborating with cross-functional teams and troubleshooting system issues. These competencies are critical to maintaining regulatory compliance, optimizing workflow efficiency, and ensuring the successful implementation and support of TrackWise solutions in an organization.

What are the most commonly searched types of Trackwise jobs in Chicago, IL?

The most popular types of Trackwise jobs in Chicago, IL are:

What are popular job titles related to Trackwise jobs in Chicago, IL?

For Trackwise jobs in Chicago, IL, the most frequently searched job titles are:

What job categories do people searching Trackwise jobs in Chicago, IL look for?

The top searched job categories for Trackwise jobs in Chicago, IL are:

Trackwise jobs near you
Infographic showing various Trackwise job openings in Chicago, IL as of August 2026, with employment types broken down into 87% Full Time, 3% Part Time, 9% Contract, and 1% Nights. Highlights an 93% Physical, 3% Hybrid, and 4% Remote job distribution, with an average salary of $107,941 per year, or $51.9 per hour.

Manager, QA

Assertio Therapeutics

Lake Forest, IL • On-site

Full-time

Re-posted 11 days ago

Job description

Overview
Job Summary
Responsible for oversight of all quality aspects related to manufacture of commercial & clinical products at contract manufacturing organizations (CMOs In partnership with QC, Regulatory Affairs, Contract Manufacturing and Project Management the QA Manager will ensure that products are manufactured in accordance with cGMPS, regulatory commitments, Assertio requirements and internal procedures.
Essential Job Functions
  • Approve master batch records, specifications, qualification & validation protocols and reports, labels, stability protocols and reports.
  • Approve/release (or reject) commercial batches.
  • Provide guidance and make recommendations regarding issues that relate to manufacturing products in accordance with 21 CFR 211, other applicable regulations and current industry standards.
  • Approve deviations, ensuring that root cause analysis and corrective actions are adequate.
  • Audit CMOs, contract test laboratories and/or raw material suppliers.
  • Manage product complaints according to procedure.
  • Establish or optimize quality systems.
  • Perform risk analysis to assess inadvertent events that may impact product identity, strength, quality, purity.
  • Advise and/or manage risk management strategies.
  • Author quality agreements and standard operating procedures.
  • Must be capable of working independently with minimum supervision.
  • Represent quality management at CMOS.

Additional Responsibilities/Duties
  • Establish/maintain effective working relationship with CMOs/business partners.
  • Partner with 'CMC' team members to ensure a cohesive unit aligned in expectations for CMO deliverables.
  • Travel estimated 25%

Education and Experience
  • Bachelor's degree or equivalent experience in related field required
  • Minimum 7 years' experience in GMP environment with at least 5 years QA experience
  • Experience with manufacturing commercial pharmaceutical products is required.
  • Prior experience with outsourced GMP activity and clinical experience strongly desired
  • Experience with method development and method validations in a QC chemistry and microbiology cGMP Manufacturing environment is desired.
  • Experience with Quality Management Systems (Trackwise, Veeva, etc.) is required
  • Experience with combination products a bonus

Skills and Abilities
  • Strong oral and written communication skills
  • Ability to recognize and accommodate cultural differences in a work environment.
  • Ability to multitask and prioritize own work schedule.
  • Computer literate (word, excel, powerpoint, etc.)
  • Good collaborative skills
  • Skilled in risk analysis/risk management strategies

Physical/Mental Demands
  • Sitting - 80%
  • Standing/ walking - 20%
  • Must be able to enter clean room environments and manufacturing areas, and to follow gowning procedures.
  • Lifting: Raising objects under 40 pounds from a lower to a higher position or moving objects horizontally
  • Repetitive motion: Substantial movements of the wrists, hands, and/or fingers for sustained periods of time. Approximately 6-hours of keyboarding per day.
  • Visual Requirements: Able to see and read PC screens and read fine print.
  • Collaboration: Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints.
  • Decision Making: Ability to make decisions which have impact on the department/company credibility, operations, and services.
  • Communication: Ability to compose letters, outlines, memos and basic reports, and to orally communicate technical information and to complete forms, use existing form letters and conduct routine oral communication.
  • Mathematics: Ability to compute, analyze, and interpret numerical data for reporting purposes.
  • Comprehension: Ability to understand, remember, and apply oral and/or written instructions or other information. Ability to understand, remember and communicate routine, factual information and to organize thoughts/ideas into understandable terminology.

Accommodations for Applicants with Disabilities
  • Assertio is proud to create a culture of inclusion and diversity and be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. We provide reasonable accommodations to qualified applicants with disabilities and to disabled veterans in accordance with the ADA. If you require a reasonable accommodation for any part of the application process due to a medical condition or disability, please email hr@assertiotx.com or call 224-441-6867for assistance.

Apply