Quality Assurance Associate

Job Title: Quality Assurance Associate

Job Description

Due to increased workload and documentation demands, this role will primarily support quality document review and eQMS administration activities. This includes routing workflows, processing change orders, and updating controlled documents. Over time, there may be additional opportunities to support process improvement and CAPA-related initiatives.

Responsibilities

• Review Batch History Records (BHRs) for completeness, accuracy, and GDP compliance prior to product release.
• Manage document control processes and quality records.
• Maintain QA documentation and support QMS activities.
• Administer training records, change control documentation, and records retention processes.
• Support complaint investigations and corrective action activities.
• Monitor and report quality metrics.
• Support nonconformance, deviation, CAPA, training, and complaint management processes.
• Partner with Operations to maintain batch records, SOPs, and labeling documentation.
• Ensure compliance with applicable GMP, FDA, ISO, and internal quality requirements.
• Provide general QA support and assist with continuous improvement initiatives.

Essential Skills

• Proficiency in quality assurance processes.
• Experience with batch record reviews and audits.
• Ability to manage document control and change control processes.
• Knowledge of pharmaceutical compliance and cGMP standards.
• Strong attention to detail and organizational skills.
• Proficiency with Microsoft Office Suite, including Word, Excel, Outlook, and PowerPoint.

Additional Skills & Qualifications

• Associate degree from an accredited institution is required.
• Bachelor"s degree in Biology, Chemistry, Engineering, Quality, or another STEM-related field is preferred.
• Previous experience in a Quality Assurance, Quality Control, or regulated manufacturing environment.
• Experience working within a Quality Management System (QMS) is preferred.
• Familiarity with ISO, FDA, GMP, or other regulated quality standards is advantageous.
• Experience with document control, records management, technical writing, or procedural documentation.
• Exposure to electronic Quality Management Systems (eQMS) is preferred.
• Quality certifications or coursework related to Quality Assurance, Quality Management, or regulatory compliance is beneficial.

Work Environment

The work schedule is 1st shift, Monday through Friday, with hours ranging from 7-8:30 am to 3:30-5 pm. The team comprises 2 QA members, 5 QC members, and 10 production team members

Job Type & Location

This is a Contract position based out of Middleton, WI.

Pay and Benefits

The pay range for this position is $23.00 - $23.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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 Middleton,WI.

Application Deadline

This position is anticipated to close on Sep 14, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.