Documentation Assistant - ECQ (Equipment Commissioning and Qualification) in Summit, NJ at Apex Life Sciences

Date Posted: 8/7/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Summit, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/7/2018
  • Job ID:
    874884

Job Description


Equipment Data Assistant - ECQ (Equipment Commissioning and Qualification)

Description:


This Candidate will receive equipment documentation to review, edit, revise and format properly. We are looking for a candidate that has knowledge or experience with GMP/ lab equipment. Below is a description of all possible tasks that may be asked of the candidate.


1)Responsibilities: 
a. Draft, revise, review, route and approve work practices, Forms, and other type of GMP documentation deliverables. 
b. Responsible for routing document deliverables through the Document Management system. 

2) Tracking Responsibilities 
a. Keeps a log of documents and their states, including types, owner, reviewers, due dates, etc. 
b. Follows up with team members and cross functional team members to encourage timely review and approval. 

3) Customer service and support 
a. Regularly reviews, prioritizes and promptly responds to customer equipment maintenance, repair and support requests. 
b. Provides technical support and guidance on calibration and maintenance issues. Interfaces with customers to ensure expectations are being met. 
c. Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment. 

4) Training and Compliance Wire Administration 
a. Act as Department Administrator for Compliance Wire 
b. Add, remove and update user information 
c. Run monthly reports on user training status 

5) Record Retention (RR) 
a. Act as RR Notification Recipient for group 
b. Ensure all department employees are trained on RR 
c. Interface with all employees to ensure compliance to RR 
d. Maintain accurate documentation of program completion 
e. Maintain up to date RR binders 

Knowledge, Skills & Abilities: 

  • Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems.
  • Basic user skills for Excel and PowerPoint are acceptable and they'll use Excel for tracking information.
  • Understands and works with all components related to web pages, i.e., web parts, lists, pages, libraries, permissions, content and forms 
     
  • Working knowledge of enterprise business systems such as Oracle or SAP preferred but not required. 
  • Strong written and verbal communication skills. Highly proficient at writing well?formulated emails and notifications.
  • Familiarity with FDA and EU environments and associated compliance regulations 

    Competencies: 

    • Professional Knowledge 
    • Problem Solving 
    • Team Player / Building Relationships 
    • Multi?tasking 
    • Customer Focus 
    • Action and detail oriented 
    • Active Listening 


    Education & Experience: 

    • AA / AS degree or acceptable combination of education and practical experience 


    Key Words:
  • Maintain documentation
  • Review documentation
  • File/Record keeping
  • Record retention
  • GMP / LAB
  • Administration
  • Internal customers and external issues

FOR IMMEDIATE CONSIDERATION please email your resume to grucci@apexlifesciences.com or call 732-636-1497

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.