Job Description

JOB TITLE: MANUFACTURING ASSOCIATE (MEDIA PREPARATION)

LOCATION: 86 MORRIS AVE, SUMMIT, NJ 07901 TENTATIVE DURATION: 06 MONTHS ASSIGNMENT (TEMP TO HIRE)

1.    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.

2.    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

·         Familiarity with Lean Manufacturing initiatives

·         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

3.    DUTIES AND RESPONSIBILITIES:

·         Oversee set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.

·         Performs 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.

·         Weights 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.

4.    EDUCATION AND EXPERIENCE:

Bachelor’s degree or Associate/ Medical Technical degree and 4 years of Manufacturing or Operations experience or High School diploma/GED and 6 years of Manufacturing or Operations experience

Qualifications null Additional Information All your information will be kept confidential according to EEO guidelines.