Quality Assurance Manager

Job Title: Quality Assurance Specialist

Job Description

Establish, maintain, and continuously improve the site Quality Management System in compliance with FDA cGMP (21 CFR Parts 210/211) and HPUS requirements.

Responsibilities

• Own and oversee quality systems including deviations, CAPAs, investigations, change control, complaint handling, and medical inquiries.
• Manage document control and records management, training and qualification programs, risk management, and quality metrics.
• Provide QA oversight for planning, manufacturing, packaging, labeling, testing, and distribution activities.
• Review and approve Master Batch Records (MBRs), executed batch records, Standard Operating Procedures (SOPs), validation and qualification documentation, product disposition, and final product release.
• Ensure appropriate controls for raw materials and homeopathic starting materials by auditing and approving suppliers.
• Lead internal and external audits and act as a quality contact during regulatory inspections by FDA, state agencies, and customers.
• Prepare and manage inspection responses, commitments, and follow-up actions.
• Mentor and train additional Quality staff.
• Analyze quality metrics and trends to identify opportunities for improvement.
• Implement best practices in quality operations and data integrity.
• Drive right-first-time manufacturing and risk-based decision-making.

Essential Skills

• Experience in pharmaceutical quality assurance, including CAPA and auditing.
• Bachelor's degree in Pharmacy, Chemistry, Biology, Engineering, or a related scientific discipline preferred.
• Progressive quality experience in a regulated pharmaceutical manufacturing environment.
• Experience in FDA-regulated manufacturing under cGMP.
• Demonstrated experience leading audits and regulatory inspections.
• Excellent analytical, writing, and investigation skills.
• Ability to interpret regulations and apply them practically in a manufacturing environment.

Additional Skills & Qualifications

• Experience with homeopathic drug manufacturing, dietary supplements, OTC drugs, or low-dose pharmaceutical products is strongly preferred.

Work Environment

This role involves working both in an office and manufacturing environment. Traditional first shift hours apply, with a start time of 7/8am being most common.

Job Type & Location

This is a Contract to Hire position based out of East Troy, WI.

Pay and Benefits

The pay range for this position is $52.88 - $72.12/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 East Troy,WI.

Application Deadline

This position is anticipated to close on Jun 8, 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 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 process due to a disability, please email ... 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.