Manufacturing Operations Associate

US-CA-Seal Beach
Job ID
2017-1026
Category
Manufacturing
Shift
Union City - Manufacturing Operations Associates

Overview

Dendreon is looking for a Manufacturing Operations Associate with 2+ years of experience in a CGMP/FDA regulated industry, with an Associate’s or Medical Technical degree.

 

The general summary of this position includes aseptic manufacturing and assembly of clinical and commercial human blood derived components in a clean-room environment (Class 10,000/ISO7, and Class 100,000/ISO8).  This job is performed in a lab, office, or utility (noisy) environment, and this person may be required to work alternate shifts.

Responsibilities

  • Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities.
  • Maintains records to comply with regulatory requirements and acts as subject matter expert for revisions or improvements to manufacturing documents.
  • Works with other Cell Processing Associates utilizing good manufacturing practices during aseptic processing of clinical and commercial products using Standard Operating Procedures.
  • Represents department in cross-functional teams, projects and GXP-related problem resolution.
  • Posts weights and shipping charges, and prepares goods for final shipment.
  • Prepares and maintains records of merchandise shipped. 
  • Prepares goods for final shipment and unpacks and checks goods received against purchase orders and invoices, maintains records of received goods, rejecting unsatisfactory items if necessary. 
  • Examines, stocks, and distributes GMP and non-GMP materials to inventory and manufacturing lines.
  • Applies job skills and company policies and procedures to complete a wide range of tasks.
  • Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.
  • Normally receives general instructions on routine work, detailed instructions on new assignments.
  • Uses ability as a skilled specialist in accordance with company policies and procedures to compete complex tasks in creative and effective ways.
  • Works on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making routine recommendations.
  • May determine methods and procedures on new assignments and may provide guidance to other support personnel.
  • Other duties as assigned.

Qualifications

  • Typically 2 years related experience in a CGMP/FDA regulated industry, or 1 year with a Associate’s  Degree or Medical Technical degree, or equivalent. 
  • Proficient in MS Office applications. 
  • Ability to sit or stand for extended periods of time. 
  • Intermittent walking to gain access to work areas.
  • Finger dexterity sufficient to use a computer and to complete paperwork activities.
  • Vision sufficient to use a computer, to read written materials and to complete paperwork activities.
  • Hearing sufficient to communicate with individuals by telephone and in person.
  • Ability to lift up to 25 pounds. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas. 
  • Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.
  • Must have the ability to work around equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.

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