KIK Custom Products

CJD 2015 - QA Documentation Reviewer

US-IN-Elkhart
3 months ago
Job ID
2017-4656
# of Openings
1
Division
KCM

Overview

Custom New Logo

 

In an efficient and effective manner, this position will review executed batch records and ensure that customer requirements are met in accordance with release specifications.  Coordinates the execution of Annual Product Reviews according to KIK SOP’s and/or customer specified requirements.

Essential Job Functions

  • Understand and follow all company policies and procedures, safety requirements, cGMP regulations and customer requirements applicable to this position.
  • Perform reviews and approvals of executed batch records.
  • Perform product final release and provide the customer with required documents.
  • Responsible for Non-Compliance Reporting follow-up tracking and report closures, documentation archive, and compile batch record dockets.
  • Review batch records for conformance to customer requirements, conformance to specifications, and completeness of information and compliance with regulatory requirements.
  • Proficient in JD Edwards Quality Assurance functions.
  • Follow up and locate missing or incomplete information. Communication with customers in resolving batch record concerns.

  • Completes assigned Annual Product Reviews in accordance with KIK SOP’s and/or customer specified requirements.

  • Provide all necessary documents for customer audits in a timely fashion and attend as requested.

 

The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.

Qualifications

High School diploma plus vocational certification or equivalent experience.

 

 

Thank you for your interest and consideration of a career with KIK!

KIK is an Equal Employment Opportunity / Affirmative Action employer.  Qualified applicants will recieve consideration for employment withour regards to race, color, religion, sex, or national origin.

Apply for this position

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Connect With Us!

Not ready to apply? Connect with us for general consideration in your area of interest.