QA Specialist

About the role

We are seeking a mid-level QA Specialist to join our dynamic team. In this role, you will be responsible for ensuring compliance and regulatory review of various documents and supporting key quality assurance programs. You will play a vital role in maintaining our company's high standards and commitment to quality.

Responsibilities

• Provide compliance and regulatory review of documents such as SOPs, protocols, and reports.
• Support the Investigations, Deviations, and CAPA programs, including handling complaints and non-conformances.
• Assist in preparing Annual Drug Product Reviews and required regulatory/compliance statements.
• Participate in Quality Systems improvement projects and validation activities.
• Support responses to questions and concerns from regulatory agencies.
• Maintain compliance with all company policies, safety, security, and regulatory procedures.
• Assist with Quality and Supplier audits as needed.
• Develop food safety plans and work on food safety protocols.
• Manage change controls and track compliance across various departments.
• Draft and write protocols for validations and equipment calibration, supporting the Master Control software.
• Track test cases to ensure they are correctly built.

Requirements

• Minimum of 2 years of experience with GMP, quality assurance, and cGMP in the pharmaceutical or biotechnology industry.
• B.S. degree, ideally in Life Sciences such as Chemistry, Biology, Biochemistry, or Microbiology.
• Experience with validation and quality control in a manufacturing setting.
• Understanding of FDA 21 CFR regulations and ICH Guidelines, with knowledge of EU and Canadian GMPs being a plus.
• Strong attention to detail and ability to work both independently and as part of a team.
• Proficiency in Microsoft Excel.
• Quality mindset with a detail-oriented approach.
• Initiative to automate and transition to electronic systems.

Qualifications

• 7+ years of experience in a quality department, preferably in QA within the pharmaceutical or dietary supplement industry.
• Ability to take initiative and work independently, with a willingness to embrace change and innovation.

Work Environment

The QA team consists of fewer than 10 members, working in an office setting. The company is committed to moving towards a more electronic and automated environment. Employees enjoy a supportive atmosphere with opportunities for growth and development.

Benefits

• Highly competitive benefits package with no premium costs for benefits
• Generous PTO policies with flexible PTO that begins immediately upon approval
• Sign-on bonus
• 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)

Pay

$28.85 - $40.87/hr

Schedule

Contract to Hire position based out of Verona, WI. This is a fully onsite position.