Job Description


Production Technician (M-W 6am-7pm) - Filling (Diag Tech)

View: 158

Company: Roche
Contract: PERM
Location: New Jersey - Branchburg, United States


Job Description

SHIFT—3 day (MON- WED) / 13 hour shift pattern (6AM – 7PM)

Summary:
Responsible for labeling, inspecting and packaging of final container products with manual and/or automated packaging systems from distribution center to customer or clinical trial sites. May also set-up, change-over and operate labeling and packaging equipment. Responsible for data entry and imprinting computer generated labels. Maintains records and manufacturing/production area to comply with regulatory requirements, good manufacturing practices and standard operating procedures. May perform initial check of completed documents for completeness and accuracy.

Responsibilities:

  • Performs tube/frame assembly, filling, labeling and pouching operations consistent with Roche quality standards.
  • Follows all department work instructions, SOPs, OSHA safety regulations.
  • Executes all manufacturing activities in accordance with cGMP/cGDP/cGLP guidelines.
  • As part of the production team will perform in-process quality checks for specific quality attributes (fill check, seal heights and label alignment check) and defects.
  • Must have the ability to wear protective gowning as manufacturing steps are performed in an environmentally controlled area.
  • Uses basic laboratory equipment to complete manufacturing and filling activities including pipettes, scales, etc.
  • Completes necessary manufacturing records legibly and accurately. 
  • Executes SAP and electronic batch record transactions to ensure all components meet requirements pertaining to lot numbers, expiration dates, intermediates, reconciliations, etc.
  • Cleans work area and decontaminates work surfaces in accordance with defined procedures and performs duties in accordance with SOPs, QSRs, and all safety regulatory requirements.
  • Monitors laboratory supply inventory, replenishes lab supplies as needed. Performs general/routine laboratory maintenance/upkeep.
  • Accountable for on-time completion of assigned corporate, safety and on-the-job training.

Qualifications:

  • High School Diploma or related field,
  • or equivalent combination of education and work experience.
  • Required: 2 years previous experience in an "Operations/Production environment " or filling, labeling or warehouse operations or equivalent combination of education and experience
  • preferably in a pharmaceutical or medical device industry.
  • Preferred:  3 years of experience in an Operations/Production environment preferably in a pharmaceutical or medical device industry.
 
 





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