Quality Investigator - Packaging

Allentown, PA

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Type: Direct-Hire

Experience: 0

Category: Scientific & Clinical

Brand: Joule

Job ID: 289873

Date Posted: 01/11/2023

Start Date: 09/12/2022

Shortcut: http://jobs.systemoneservices.com/hQFIQd


Title: Quality Investigator - Deviation Investigations 

Location: Allentown, PA  

Schedule: Hybrid M-F standard business hours

Start date: Immediate
 

Responsibilities:

  • Identifies issues and can independently assess the need for non-conformance and formulate recommended containment actions in conjunction with operational leadership.
  • Conduct investigations that identify robust root causes by effectively applying root cause analysis tools across a variety of non-conformance and/or complaint types.
  • Independently lead and/or facilitate floor gembas, cross-functional meetings, and operator interviews related to investigations.
  • Observe processes on the shop floor, warehouse, and central support functions (incoming inspection, sales, customer service, project management, validation, and engineering) to ensure the investigation is factual and detailed.
  • Author investigation reports in designated QMS utilizing strong organizational and technical writing skills with demonstrated attention to detail.
  • Drives collaboration utilizing strong interpersonal communication skills
  • Lead effective cross-functional root cause analysis and CAPA and Continuous Improvement planning and execution with minimal supervision.
  • Owns data collection and performance metrics relative to the investigation process and CAPA effectiveness and facilitates sharing of investigational findings and risk knowledge through the organization.
  • Initiates, writes, reviews, and assesses change controls and revises SOPs and Work Instructions as needed for action implementation.
  • Utilizes knowledge, experience, and critical thinking skills to recommend potential product impact outcomes and provides thorough supporting documentation and justification for those outcomes.

Requirements:

  • Bachelor’s degree is preferred with one to three years of related experience or an Associate's Degree with three to five years of related experience.
  • Experience in the packaging or inspection of pharmaceutical products or related industry is required.
  • Outside certification of quality skills and practices (i.e. ASQ, CQIA, CQI, CQT, Lean Six Sigma etc.) is highly desired.

 

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.


System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.


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