Quality Assurance Specialist

Job Title:

Quality Assurance Specialist

Job Description

The Quality Assurance Specialist will support critical documentation and technology transfer projects by transferring, reformatting, and maintaining Standard Operating Procedures (SOPs) and related documentation. The role focuses on immunoassay, formulation, and cell culture transfer projects, ensuring that legacy documents are accurately migrated into current SOP templates in a regulated GMP environment. This position offers the opportunity to contribute to new product introduction, site transfer initiatives, and continuous improvement activities within operations.

Responsibilities

* Transfer and reformat existing Standard Operating Procedures (SOPs) and related documents into current SOP templates with a high degree of accuracy and consistency.

* Review legacy documentation for immunoassay, formulation, and cell culture transfer projects and ensure all relevant information is captured and updated in new formats.

* Perform data entry and documentation updates in accordance with GMP requirements and internal quality standards.

* Support documentation activities associated with technology transfer projects involving cell culture, particles, and formulation work.

* Apply working knowledge of SOP writing to create, revise, and maintain clear and compliant procedures.

* Utilize production formulation experience, including weighing materials and chemicals, operating equipment such as spectrophotometers, and measuring pH, to ensure technical accuracy of documents.

* Contribute to quality assurance processes by supporting the creation and maintenance of CAPAs (Corrective and Preventive Actions) and supplier notifications.

* Work with change order and inventory management systems to track and control document and process changes.

* Collaborate with a cross-functional team focused on new product introduction, site transfer projects, CAPAs, end-of-life products, maintenance requests, and supplier notifications.

* Maintain meticulous attention to detail and organization while working at a desk in a documentation-focused role.

* Demonstrate an interest in continuing with the organization beyond the initial documentation project, contributing to ongoing quality and operations initiatives.

Essential Skills

* Bachelor's degree in a life science discipline such as chemistry, biology, biochemistry, or microbiology.

* At least 6 months of experience working in a GMP (Good Manufacturing Practice) environment.

* At least 6 months of experience with writing or contributing to SOPs.

* At least 6 months of production formulation experience, including weighing materials and chemicals, utilizing a spectrophotometer, and measuring pH.

* At least 3 months of experience working around immunoassay manufacturing.

* Demonstrated experience in quality assurance or closely related laboratory quality functions.

* Strong data entry skills with high accuracy and attention to detail.

* Ability to follow and interpret laboratory and formulation procedures.

* Solid understanding of documentation practices in a regulated environment.

Additional

Skills & Qualifications

* Experience with writing or supporting CAPAs (Corrective and Preventive Actions).

* Experience preparing or managing supplier notifications.

* Familiarity with change order systems and inventory management systems.

* Background or coursework in biochemistry or chemistry is beneficial.

* Interest in long-term career growth and continuing internally after the initial project.

* Strong organizational and time-management skills to handle multiple documentation tasks and projects.

* Ability to work effectively with a team focused on new product introduction and site transfer activities.

* Comfort working in a highly documentation-driven, quality-focused role.

Work Environment

This is a full-time, Monday-Friday, first-shift position, with flexible start times between 6:00 a.m. and 9:00 a.m., and an 8.5-hour workday. The role is 100% desk-based and centers on documentation and quality assurance activities rather than hands-on bench work. You will join a team that recently underwent a reorganization and is focused on new product introduction in operations, site transfer projects, CAPAs, end-of-life products, maintenance requests, and supplier notifications.

Most team members have biochemistry or chemistry backgrounds, with additional expertise in product labeling and inventory management. The environment emphasizes collaboration, accuracy, and adherence to GMP and quality standards while supporting technology transfer projects involving cell culture, particles, and formulation work.

Job Type & Location

This is a Contract to Hire position based out of Chaska, MN.

Pay and Benefits

The pay range for this position is $28.00 - $30.00/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…