Laboratory Associate (Pharmaceutical):
Spectraforce Technologies Inc

Spectraforce Technologies Inc
Summit New Jersey

Job Title: Manufacturing Associate - level I
Job Location: Summit, NJ 07901
Duration: 6 Months (Temp to Perm):

Entry-level Job role: Recent Graduates can also apply

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.
  • Weighs and measures in-process materials to ensure proper quantities are added/removed.
  • Adheres to the production schedule ensuring on-time, internal production logistics.
  • Records production data and information in a clear, concise, format according to proper GDPs.
  • Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
  • Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
  • Motivated, team consciousness individuals are needed to fulfill job requirements.
  • Become a SME and qualified trainer within a designated function of manufacturing.Supervision will be managed by the shift Supervisor or designated Team Lead.
  • Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge.
  • Performs other tasks as assigned: continuous improvement projects, inspection readiness, right first-time initiatives, etc.

Job Requirements:

Education and Experience:

  • Bachelor's degree or Associate/ Medical Technical degree and 3 years of Manufacturing or Operations experienceor High School diploma/GED and 2 years of Manufacturing or Operations experience.

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
Basic Qualifications