Continuous Improvement Specialist in Warren, NJ at Apex Life Sciences

Date Posted: 6/4/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Warren, NJ
  • Job Type:
    Other
  • Experience:
    Not Specified
  • Date Posted:
    6/4/2018
  • Job ID:
    855137

Job Description


  • The Continuous Improvement Specialist is responsible for supporting major deviations/investigations and CAPAs in regards to Manufacturing Operations.
  • In addition, they will also be responsible for assisting in developing and maintaining various programs and systems to ensure compliance and quality.
  • This may include but not be limited to training, trending and continuous improvement endeavors. 

Responsibilities: 

Under the direction of the Manufacturing Operations Continuous Improvement Team, work cross-functionally to perform the following: 

  • Initiate deviations and perform routine investigations 
  • Participate in cross functional investigative teams deploying specific investigative principals as necessary to ensure root cause analysis and corrective action(s) 
  • Ensures corrective actions and improvements are shared and incorporated into the appropriate processes 
  • Generate and execute CAPA documents to support response to deviations, audit findings and independent corrective actions 
  • Collaborate with QC team to prioritize and lead Continuous Improvement initiatives 
  • Basic understanding of site quality systems 
  • Interact and collaborate with departments (on and offsite) as well as vendors, consultants, and other external services providers 
  • Generate risk assessment as necessary to support deviations, CAPA, SOP revision, and program development 

Requirements: 

  • B.S. in a scientific or engineering discipline 
  • 2 or more years relevant experience, preferably in a GMP or regulated environment 
  • MOST IMPORTANT - Experience writing deviations and investigations.
  • Basic proficiency in MS Word, Outlook, Excel, PowerPoint, and Visio 
  • Basic knowledge of cGMPs 
  • Ability to work independently without direct supervision and work within cross-functional teams 

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.