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Job Description


Production Lead Specialist, Operations - Packaging, 2nd shift

View: 217

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


Lead Diagnostic Tech Specialist, Operations - Packaging, 2nd shift (3pm-11:30pm)

This position is eligible for a Shift Differential. 

Responsibilities:

  • Supervises a 2nd shift operation and personnel of multiple packaging production line centers producing intermediate components and finished products. Walks the shop floor and oversees day to day activities.
    • Ensures that all necessary production documentation (batch production records) and associated SAP transactions are performed
    • Coordinates Packaging schedule and its execution.  Schedules production lines to ensure all available personnel are deployed to meet packaging schedule requirements.  Individual is skilled in the operation of all automatic and semi-automatic labeling, and Packaging/warehouse equipment to ensure personnel coverage is assigned.
    • Ensure all Packaging/Labeling tasks are performed in accordance with corporate policies, SOPs, QSRs, external agencies (e.g., FDA, ISO) as well as all safety regulatory requirements (OSHA). 
    • Supervises the review of completed production paperwork for completeness and accuracy. During the review process, ensures all in process testing steps performed and documents during the production operation meet all required specifications.
    • Assist in training of junior staff on all area operation activities. 
    • Ensures inspection of products for defects and conformance to quality standards and applicable SOPs is performed.
    • Understands GMP, QSR, ISO and RMS Quality regulations and ensure that all production operations are performed in a manner that meets these requirements. 
  • Maintains SAP production schedule and dispatches SAP phases based on production schedule progress.  Perform Goods Issues and Receipts for manufacturing batch runs. Runs SAP reports to review department direct hours and accuracy to recipes. 
  • Provide guidance and training to new team members. Manage training of individuals in responsible areas and ensure training is current.
  • Lead internal/external teams and build professional relationships. Serves as a resource to other departments and provides timely response and follow-ups.  Resolves issues encountered in the logistics and planning processes to improve performance.
    • Able to represent Packaging team and speak on behalf of the department to outside areas. 
  • Participates in area audits as necessary and assists/leads in area tours of the operations.  Collaborates with team to drive CAPAs/QARs to completion in appropriate timeframes. Collaborates on all area related change management activities.
  • Issue work orders and contact outside vendors for parts or repairs.  Participate in the execution and co-authorship of Validation protocols.
  • Recommends and can drive and implement process improvements and/or lead projects to successful achievement. 

Education:

  • Minimum required: High School Degree or equivalent combination of education and work related experience.
  • Preferred: Associates Degree.

Job-related Experience:

Minimum required:

  • 5 years of experience in supervising filling, packaging, operations, preferably in a pharmaceutical or medical device industry.

Preferred:

  • 7 year previous experience in supervising filling, labeling or warehouse operations in a pharmaceutical or medical device industry.
  • Familiar use of automated and computerized systems including SAP, Trackwise, basic office management software (Excel, Word, Google mail, etc.). 
  • Leadership demonstration.
 
 
 
 
 
 





More Info / Apply

(external link to recruiter web page)








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