Signature Biologics is a biopharmaceutical company developing novel cellular and biologics to provide medical relief to patients with unmet clinical needs.
At Signature Biologics, we have decades of experience in human perinatal biologics both domestically and internationally.
Essential Duties and Responsibilities:
Perform related duties as assigned by Laboratory Management.
Responsible for all activities related to materials decontamination and/or sterilization – pre/post clean of materials, proper operation of sterilizers and verification of indicators of sterilization cycles.
Responsible for performing the random sampling of different lots to select samples for testing.
Ensure proper packaging and shipping of samples for external testing and final product according to established procedures.
Perform the preventive maintenance of designated equipment such as: sterilizers, freezers, and biosafety cabinets.
Prepare and transfer manufacturing materials for use during aseptic processing operations.
Prepare cleanroom areas for manufacturing processes.
Use microscopes to evaluate cell culture for manufacturing processes.
Support tracking of disposed tissue.
Ensure final product is placed in the designated areas for approved, quarantine and rejected product, update the areas as needed.
Maintain and report inventories and/or discrepancies.
Perform physical inventory count of product if required.
Perform the daily fulfilment of orders using NetSuite.
Participate in the annual Internal Audit process.
Be familiar with applicable regulations and standards described in the Quality Manual.
Maintain good documentation practices for all records used in manufacturing.
Education and/or Work Experience Requirements:
High school diploma or GED required.
Bachelor's degree in Biology or Life Sciences preferred.
Experience in laboratory manufacturing preferred.
GMP or aseptic technique experience a plus.
Excellent verbal and written communication skills.
Excellent computer proficiency (MS Office – Word, Excel and Outlook)
Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary work product
Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices.
Physical Requirements:
Must be able to lift, carry, and move up to 50 lbs.
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