Job Description
Job DescriptionJob 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 May 6, 2026.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.