Lab Technician - QA & QC (Environmental Testing)

Provides key Quality and Laboratory support to the StimLabs organization

Operates under the supervision of Quality Management.

Performs testing to ensure correct composition and to identify any quality issues.

Participate in sample preparation and critical thinking in collaboration with Operations.

Collects and tests environmental monitoring samples from the cleanrooms and associated controlled areas

Acts as primary lab technician performing daily testing, such as mechanical testing (e.g. peel strength) and analytical testing (e.g. residual moisture, content analysis, cell culture) and microbiology testing.

Suggests and implements improvements of sample testing and test methods.

Acts as a laboratory representative within the organization, raising awareness for laboratory standards and education.

Contributes to the development of lab-related infrastructure for new products.

Assists or lead on a variety of projects as designated by Quality Management.

Conducts activities and documentation related to Quality Control. Participates in daily operations of the Quality department including but not limited to:

Setting up Quality Control laboratory equipment and performing Quality testing.

Assists or manages calibration of lab equipment in preparation for specific tasks.

Prepare samples and reagents for testing and retention.

Follow all company policies and procedures to ensure product integrity and quality control.

Analyze retrieved data and prepare laboratory reports to management.

Recognize and report any product safety issues.

Provide critical thinking for problem solving.

Develops, validates and implements mechanical and analytical test methods.

Assists with incoming inspection and release of all raw materials (including donor tissue when applicable), components, sterilized bulk product, and supplies to ensure compliance with applicable regulations and requirements.

Assists and collaborates on development of Standard Operating Procedures, Work Instructions, Forms, sampling plans, and specifications.

Assists with in-process and finished product Quality Control inspections of materials and products to ensure compliance with product specifications and regulatory requirements (residual moisture analysis, package integrity, sterilization verification, dimensional specifications, visual inspections, etc.).

Reviews biological indicators from sterilization cycles to ensure sterilization cycle parameters and specifications were met.

Performs with environmental monitoring sampling (viable air, viable surface and non-viable particulates) and testing as needed.

Collaborates with Quality and/or Operations to complete investigations related to laboratory failures or out-of-specification events and documentation.

Assists with investigations and documentation of CAPAs, Deviations, Nonconformance Reports, and Complaints, as directed by Quality Management.

Maintains laboratory testing schedule to ensure test results are available in a timely manner.

General administrative tasks such as scheduling, filing, organizing etc.

Assists with general lab cleaning and upkeep on a regular basis.

Maintains MSDS records for laboratory reagents and chemicals.

Assists in keeping up with lab component maintenance schedules.

Assists with taking lab inventory and ordering lab supplies as needed.

Support inspections and audits from regulatory agencies, as needed.

Assists in training employees on new tasks/functions when designated by Quality Management.

Performs additional activities as assigned by Quality Management. EDUCATION/CERTIFICATION

Bachelor's degree in a technical/relevant field, with at least three to five (3-5) years of Quality Control experience in a pharmaceutical, medical device, biologic, or tissue banking FDA regulated facility; or an appropriate combination of education, certification and work experience. REQUIRED KNOWLEDGE

Knowledge and understanding of regulatory requirements, including 21 CFR 1271, AATB, cGTP, cGMP, 21 CFR 820, 21CFR 211, and other applicable state and federal regulations. Document Control Management (document changes as well as maintenance of Quality records) in a cGMP regulated environment required. Capable of prioritizing tasks to meet goals and ensure product quality. Experience in tissue banking preferred but not required.

StimLabs was founded in 2015 with a desire to advance the state of regenerative medicine. In pursuit of this goal, StimLabs has gathered exceptional scientific and clinical minds to develop and commercialize new bioactive technologies. While current technologies in medical devices, pharmaceuticals, and tissue banking provide useful products, StimLabs believes in the untapped synergy at the intersection of these independent domains. In the first steps towards this vision, StimLabs has launched a suite of next-generation amniotic-derived products. The success of these initial offerings has created a foundation on which StimLabs will continue building the future of regenerative medicine.