Process Improvement Specialist in Bloomsbury, NJ at Volt

Date Posted: 4/15/2021

Job Snapshot

  • Employee Type:
    Direct Hire
  • Job Type:
  • Duration:
    N/A
  • Date Posted:
    4/15/2021
  • Job ID:
    278734
  • Contact Name
    Volt Branch
  • Phone
    516-228-6788

Job Description

Volt is immediately hiring a Process Improvement Specialist   to join a top company in Hunterdon County NJ

 Responsibilities:

 Lead teams of personnel dedicated to research, design, and execution of new product formulation introduction and commercialized product improvement objectives

Support development of appropriate Beyond Use Dating based on product formulation capabilities

Provide technical assessment of product formulations with respect to container closure and delivery systems

 Partner with Quality Compliance in the development and routine implementation of quality processes required to support technical related programs (i.e. Change Control, Investigations, Master Batch Records, etc.)

Engage with Commercial Operations to ensure production processes are appropriately designed to ensure on-time supply of products to meet customer requirements

Ensure appropriate systems are in place as required to meet DEA requirements for controlled substances

Provide Quality Partners, Commercial Operations, and Executive Management visibility of shop floor concerns related to production performance

 Provide hands on support in the phased introduction of process improvements required to meet Personnel and Material flow pattern objectives

Support execution of program requirements for Aseptic Operator and Process Simulation requirements

Investigate and execute risk-based solutions deemed necessary to address business operational and compliance challenges related to production processes

Provide validation impact assessments for change controls including directing the identification and execution requirements deemed necessary to ensure quality and production robustness over time

Support development and execution of Cleaning Validation

 Ensure effective communication and collaboration between Commercial Operations, Quality Compliance partners and operational shop floor personnel

Qualifications:

Bachelor’s Degree in Chemistry, Biology, Pharmacy, or an appropriate science related discipline required; Or, equivalent education and relevant work experience in the Pharmaceuticals industry will be considered

Masters Degree preferred

Minimum five years’ experience in the manufacture, testing, and distribution of sterile Pharmaceutical/Biological products. This includes experience in site-based manufacturing and/or quality operations roles

Experience at multiple sites and across multiple functions is preferred

Incumbent must process strong analytical and problem-solving skills, good communication skills, project management experience, extensive knowledge of GMPs, and ability to make decisions in a constantly changing environment

Volt is an Equal Opportunity Employer