Quality Technician

Job Title

Location: Onsite in Eden Prairie, MN

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN, Eden Prairie and Glencoe, MN, Neunkirchen, DE, Glasgow, UK, and Marton, NZ.

Job Responsibilities

• Support quality department with building qualifications.
• Work with the quality team to organize, coordinate, and execute building and testing of equipment per written or standard operating procedures
• Author reports as required to document and communicate results
• Undertake laboratory analysis and the monitoring of microbial cultures, samples.
• Investigate the growth, structure development, and other characteristics of microscopic organisms such as bacteria, algae, and fungi.
• Supervise and conduct research on various microbiological activities on a regular basis.
• Maintain knowledge on various research methods and perform all manual operations on various supplies, surfaces, and materials.
• Help develop and maintain validation in all protocols for various environmental controls.
• Perform laboratory analysis on all materials after appropriate sterilization.
• Perform tests on component samples, identify any contamination, conduct an analysis, and initiate corrective measures.
• Study various cultures of microorganisms in isolation according to standard inhibition and ensure control over moisture and temperature.
• Monitor all physiological and morphological characteristics and identify microorganisms. Perform tests on all incoming ingredients and document all records.
• Develop and prepare research papers and documents for all protocols.
• Perform audits on various environmental programs and perform reviews.
• Develop various testing processes for all raw materials and equipment and monitor all finished products. Investigate all issues and prevent any GMP problems on samples.
• Maintain accurate records and perform tests on all activities conducted in the laboratory. Develop and document various microbiology laboratory processes and prepare final reports.
• Maintain purchase orders for all laboratory processes and monitor inventory.
• Review product batch records in a timely manner and communicate issues with area supervisors. And prepare paperwork for shipping.
• Contribute to implementation of new requirements and compliance with the quality management system.
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices.
• Contributes to team effort by accomplishing related results as needed.
• Take on additional Responsibility as directed by management.

Education

• High School diploma or equivalent

Experience

• 0 to 3 years of experience in quality assurance or quality control

Certification

• N/A

Skills

• Must have very good organizational skills with attention to detail
• Must be able to perform multiple tasks simultaneously and accurately
• Must be able to adjust rapidly to shifting priorities and variable workloads
• Must have adequate computer skills for data acquisition, data management and visualization of experimental results
• Work under minimal supervision
• Effective problem solving and decision-making skills
• Knowledge of Outlook, MS Excel, MS Word, MS PowerPoint

Safety

• Move or lift objects up to 25 pounds
• Frequent (>75%) stationary position (standing or sitting) while utilizing digital
• Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

Working Environment

• Onsite: Office environment with assigned workstation

At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.

Montagu Private Equity ("Montagu"), a leading European private equity firm, acquired Evergen in 2020 and has supported the transformation of the company to its next level of potential.