Quality Technician
About The Position
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 has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ. This role supports the quality department with building qualifications, organizing, coordinating, and executing equipment building and testing, and authoring reports. The position also involves laboratory analysis, monitoring microbial cultures and samples, investigating microscopic organisms, conducting research on microbiological activities, maintaining knowledge of research methods, developing and maintaining validation protocols for environmental controls, performing laboratory analysis on sterilized materials, testing component samples, identifying contamination, conducting analysis, and initiating corrective measures. Additionally, the role includes studying microorganism cultures, monitoring physiological and morphological characteristics, identifying microorganisms, testing incoming ingredients, documenting records, preparing research papers, performing audits on environmental programs, developing testing processes for raw materials and equipment, monitoring finished products, investigating issues, preventing GMP problems, maintaining accurate laboratory records, documenting microbiology laboratory processes, preparing final reports, maintaining purchase orders, monitoring inventory, reviewing product batch records, communicating issues, preparing shipping paperwork, contributing to the implementation of new requirements and quality management system compliance, maintaining professional and technical knowledge, and contributing to team efforts. The company is committed to fostering an inclusive workplace that embraces diversity and ensures every voice is heard, respected, and celebrated. Montagu Private Equity acquired Evergen in 2020 and has supported its transformation.
Requirements
- High School diploma or equivalent
- 0 to 3 years of experience in quality assurance or quality control
- Very good organizational skills with attention to detail
- Able to perform multiple tasks simultaneously and accurately
- Able to adjust rapidly to shifting priorities and variable workloads
- 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
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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
