Quality Assurance Associate

Quality Assurance Associate

The Quality Assurance Associate plays a key role in ensuring products meet all applicable quality and regulatory standards by reviewing batch documentation, maintaining quality records, supporting quality management system activities, and partnering closely with Operations to drive continuous improvement.

• Review Batch History Records (BHRs) for completeness, accuracy, and Good Documentation Practice (GDP) compliance prior to product release.
• Manage document control processes and maintain accurate, up-to-date quality records.
• Maintain Quality Assurance (QA) documentation and support Quality Management System (QMS) activities.
• Administer training records, change control documentation, and records retention processes in accordance with quality procedures.
• Support complaint investigations and corrective action activities to ensure timely resolution and prevention of recurrence.
• Monitor, analyze, and report quality metrics to support data-driven decision making.
• Support nonconformance, deviation, corrective and preventive action (CAPA), training, and complaint management processes.
• Partner with Operations to maintain batch records, standard operating procedures (SOPs), and labeling documentation.
• Ensure compliance with applicable GMP, FDA, ISO, and internal quality requirements across all QA activities.
• Provide general QA support to cross-functional teams and assist with continuous improvement initiatives.

• Associate degree from an accredited institution.
• Proficiency with Microsoft Office Suite, including Word, Excel, Outlook, and PowerPoint.
• Strong attention to detail and a high level of accuracy in reviewing and managing documentation.
• Effective organizational skills with the ability to manage multiple quality records and tasks in a fast-paced environment.
• Ability to work within established quality procedures and regulatory requirements.
• Foundational understanding of quality assurance concepts such as batch record review, CAPA, audit support, document control, and change control.
• Ability to communicate clearly and professionally in both written and verbal formats.

• Bachelor's degree in Biology, Chemistry, Engineering, Quality, or another STEM-related field.
• Previous experience in a Quality Assurance, Quality Control, pharmaceutical, or other regulated manufacturing environment.
• Experience working within a formal Quality Management System (QMS).
• Familiarity with ISO, FDA, GMP, HACCP, or other regulated quality standards and compliance frameworks.
• Experience with document control, records management, technical writing, or procedural documentation.
• Exposure to electronic Quality Management Systems (eQMS).
• Quality-related certifications or coursework in Quality Assurance, Quality Management, or regulatory compliance.
• Experience supporting audits, complaint investigations, and continuous improvement initiatives.

This role is based in an office and laboratory setting at a Parmenter Street location. The position follows a first-shift schedule, Monday through Friday, from 8:00 a.m. to 4:30 p.m. The work environment involves collaboration with Operations and other quality-focused teams, use of standard office technology and quality documentation tools, and adherence to appropriate lab and office attire and safety practices.

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

The pay range for this position is $25.00 - $25.00/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…