Job Title: Manufacturing Associate - Liso Cel Job Location: Summit, NJ 07901 Duration: 6 Months (Temp to Perm)
*** For Entry Level Candidates with a Bachelors in Biology or related field***
Purpose and Scope of Position Manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. Day shift structures are Quad 1 or Quad 3, 5 am-5:30 pm, Sunday through Wednesday or Wednesday through Saturday. Night shift structures are Quad 2 or Quad 4, 5 pm to 5:30 am, Sunday through Wednesday or Wednesday through Saturday. Start and end times are subject to change based on business demands. Duties and Responsibilities:
Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
Support deviation investigations and write ups as needed.Support on time closure of any assigned CAPAs within the designated shift.
Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum. Aseptic qualification is required.
Required Competencies: Knowledge/ Skills, and Abilities:
Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
Knowledge of cGMP/FDA regulated industry
Basic mathematical skills
General understanding of cGMPs
Technical writing capability
Proficient in MS Office applications
Background to include an understanding of biology, chemistry, medical or clinical practices
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