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Job Title: Quality Assurance Analyst

Job Description

The Quality Analyst is responsible for assuring that activities, processes, and products related to managing the processes of CAPA, Change Management, investigations, deviations, Quality Management Review, Audit coordination, and metrics. This position will involve a wide range of tasks which may include Quality System improvement initiatives, data maintenance, trending and reporting, deviation investigation, internal/external auditing, and direct involvement and collaboration with the Regulatory Affairs, Operations, Technical Operations, Engineering, and Materials Management groups to drive quality culture.

Responsibilities

+ Develop and maintain quality system processes

+ Manage CAPA initiation, review, surveillance, and reporting

+ Facilitate the site Quality Management reviews

+ Facilitate and lead the site Change Management process

+ Coordinate facility audits by internal and external entities

+ Manage data collection and reporting when product recalls are required

+ Support and lead RCA’s through cross-functional team involvement

+ Perform trending of Quality Systems to support FDA and Management reviews

+ Coach and mentor others regarding QMS and Quality Culture, including leading Good Documentation Practice training and Quality on the Floor coordination and performance

+ Improve existing procedures to align with cGMP and regulatory requirements

+ Interpret and properly apply all applicable regulatory requirements

+ Improve quality culture through site initiatives

+ Review and approve procedures, protocols, reports, etc.

Essential Skills

+ Bachelor’s, or higher, degree in a science/technology program

+ 5+ years of experience in a cGMP Quality Assurance/Compliant environment (medical devices preferred)

Additional Skills & Qualifications

+ Experience with quality assurance processes

+ Knowledge of FDA regulations

+ Experience in audit coordination

+ Strong understanding of quality systems management

+ Proficiency in change management

Work Environment

The position operates in an office environment with core hours from Monday to Friday, 8am-5pm.

Pay and Benefits

The pay range for this position is $30.00 - $40.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Madison,WI.

Application Deadline

This position is anticipated to close on May 27, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.