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Manufacturing Associate

Spectraforce Technologies Inc Ayer, MA Full-Time
$37,440.00 - $56,160.00 / year
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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

Recommended skills

Biology
Cell Cultures
Cell Therapy
Manufacturing
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