Quality Assurance Associate

Job Description

Job Description

We are looking for a Quality Assurance Associate to join a high-tech pharm/biotech environment in Middleton, Wisconsin. This Long-term Contract position is well suited for an early-career quality specialist who is organized and comfortable working with regulated documentation and quality processes. The role will support core quality operations by helping maintain accurate records, reviewing documentation, and partnering with cross-functional teams to uphold compliance and quality standards.

Responsibilities:
• Review batch history records to verify accuracy, completeness, and alignment with approved documentation practices.
• Maintain controlled documents and quality records by organizing, updating, and filing materials in accordance with established procedures.
• Contribute to quality system activities involving training documentation, change control, record retention, customer feedback tracking, and quality metric reporting.
• Assist with complaint reviews and follow-up quality actions under the guidance of quality assurance leadership.
• Gather, compile, and communicate assigned quality and operational metrics to support departmental visibility and performance monitoring.
• Work closely with Operations and partner teams to ensure required quality documentation is completed correctly and retained appropriately.
• Support ongoing administration of quality management system processes, including training records, nonconformance tracking, and corrective and preventive action documentation.
• Follow company policies, regulatory expectations, and applicable quality standards while participating in daily quality assurance activities.
• Take part in continuous improvement efforts and support additional quality-related assignments as business needs evolve.

• Associate degree from an accredited institution or similar experience.

• At least 1 year of experience in quality assurance, documentation review, testing, or a related function.

• Proficiency with Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint.

• Strong attention to detail with the ability to manage records accurately in a regulated or process-driven environment.

• Clear written and verbal communication skills, with the ability to collaborate across departments.

• Familiarity with quality management systems, document control, or records management is preferred.

• Previous experience in manufacturing, biomanufacturing, or another regulated industry is preferred.

• Exposure to process documentation, manual testing, or quality-related reporting is a plus.