Quality Assurance Associate

Spring Point Project is committed to improving the lives of people with Type 1 diabetes by providing a virtually unlimited supply of medical-grade, high-health pigs to serve as safe islet cell donors to people with diabetes.

We envision a world without diabetes, a world where monitoring and daily insulin injections are no longer a part of anyone's life.

Position Title Quality Assurance Associate

Position Objective The Quality Assurance (QA) Associate reports directly to the Director of Quality. The QA Associate performs activities associated with the quality assurance of porcine islets, encapsulated islet combination products, systems, and components thereof. The QA Associate assists the Director of Quality to ensure that all products produced at Spring Point Project adhere to Spring Point Project’s Quality Management System, client, vendor, and pertinent, associated quality and regulatory requirements.

Key Responsibilities and Duties

• Responsible for Quality support at Spring Point Project and may include oversight via direct staff management or process/area responsibilities.
• Identify and assess regulatory and quality risk in activities and processes according to regulatory agency rules and guidelines along with Spring Point Project quality practices.
• Assist in management of Quality Management Systems, CGMP training, Master Validation Plan, and Continuous Improvement Program. This includes both large- and small-scale projects to support compliance and FDA product approval for interstate commerce.
• Write, review, assess, and revise Standard Operating Procedures (SOPs) and submit procedural changes as needed.
• Apply working knowledge and experience with all federal and state regulations and requirements and industry standards related to FDA and USDA regulated products.
• Conduct vendor and internal audits and inspections.
• Adhere to and support safety standards, policies, and practices.
• Assist Document Control personnel with document administration functions as needed.
• Other assignments as required.

Minimum Qualifications and Experience

• A minimum of 2 years of QA experience in GMP, GLP, and/or ISO regulated environment
• Strong understanding of GLP/GMP regulations and practices
• Excellent communication skills, both verbal and written. Fluency in Japanese is a plus
• Highly detail-oriented and organized
• Good problem solving and critical thinking skills
• High level of computer proficiency, knowledge of IT terminology and application of computer system regulatory practices (e.g. 21 CFR part 11 compliance, data integrity, Excel spreadsheet validation)
• Proficiency demonstrated using word processing, spreadsheet, and database computer programs
• Professional experience using electronic Quality Management Systems (eQMS) preferred
• Occasional ability to travel overnight as needed
• Proficient knowledge of medical terminology a plus
• Experience conducting statistical analyses of data and the interpretation of results preferred
• Experience of operating within an aseptic clean room environment preferred
• Must have the ability to perform multiple tasks simultaneously and work cross-functionally in a highly matrixed work environment
• Must have the ability to work effectively under pressure in a fast-paced, deadline-oriented environment
• Must be able to work independently, at times remotely, and with minimal supervision
• Due to extreme high herd health the position is contingent upon meeting strict biosecurity (primarily personal and intimate contact’s swine contact/withdrawal time), background, and pre-employment health screening requirements.

Education and/or Experience

· 4 years of industry experience in a cGMP production environment in a QA role with demonstrated proficiency in conducting audits, documentation generation, review, and continuous improvement, or 2 years of such experience with Quality Certification

· B.S. or M.S. preferred

· Project management certification a plus

This Job Description is intended to describe the general contents of and the requirements for the performance of this job. It is not intended to be, nor may it be construed to be, a complete and exhaustive statement of duties, responsibilities, or requirements.

This Position Description is subject to change as the needs of Spring Point Project and the requirements of the position change. Additional, alternative, or new responsibilities and special projects may be assigned.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: Hybrid remote in New Richmond, WI 54017