- Participates in aseptic processing of clinical and commercial grade product according to cGMPs.
- Maintains training records according to site and departmental procedures
- Trains others as needed
- Drafts and edits SOP’s and batch records to support cell therapy products
- Stocks cleanroom suites and support areas with released inventory
- Provides support in maintaining cleanroom environment below alert limits by following established cleaning practice.
- Inventory control including but not limited to: ordering, allocation, cycle count participation.
- Packages kits, blood tubes and final product for shipment
- Monitors critical equipment (i.e. temperature, CO2, O2, calibration status).
- Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
- Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
- Ensure that all team members comply with safety rules and regulations.
- Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Has knowledge of commonly used concepts, practices, and procedures within a particular field.
- Relies on limited to moderate experience and judgment to plan and accomplish goals.
- Works under general supervision.
- A certain degree of creativity and latitude is required.
- Bachelor’s degree in Life Sciences and 2-4 years experience or a H.S. diploma/Associate’s degree or equivalent with 5-7 years of experience in a cGMP clinical production environment.
- Aseptic technique and experience in cell culture and serological methods preferred
- Able to pass Class 10,000/ISO 7 gown validation
- Knowledge of cGMP and clean room behavior preferred
- Computer software skills including Microsoft Office and SAP, organization skills, recordkeeping skills, ability to manage multiple projects, time management skills.
- Written and oral communication skills, team oriented, independent work skills, strong work ethic.
About Tech USA
Tech USA, Scientific Solutions is a comprehensive provider of staffing and workforce solutions throughout the Scientific Industries, including Biotechnology, Pharmaceutical, Clinical Research, Healthcare, Medical Biodefense, Environmental, Chemical and Food Sciences. We are actively seeking candidates for contract, contract-to-hire and permanent placement jobs throughout the nation. View our website to see a list of our current open positions; however, not all of our positions are listed so don’t forget to submit your resume and request a consultation with one of our scientific recruiting specialists to explore your opportunities further.
At Tech USA we understand that next to your family, your career is one of the most important aspects to a happy and fulfilling life. This is why we take the time to truly understand and get to know our candidates, so we can then pair them with the right job, not just any job. As a result, Tech USA is known throughout the industry for quality, reliability and the highest satisfaction from both our clients as well as the candidates that we represent. TechUSA is an equal opportunity employer.