CSL Behring Change Control Specialist in Kankakee, Illinois
Change Control SpecialistUnited States of AmericaR-0931192010 CSL Behring L.L.C.
Defines the implementation plan for changes and ensures all sequence steps within change control are performed in correct order.
Evaluates change and risk to product SQuIPP. Determines if batch tracking is required.
Evaluates change for completeness and issues approval for change (Release to Operation).
Participates in project teams (including shutdown teams) focused on the development and improvement of existing, and the installation of, new equipment and systems.
Communicates and coordinates with representatives of Manufacturing, Validation, Regulatory, Engineering, Compliance and other site personnel to obtain necessary background information and technical data to assure timely review and completion ofchange controls.
Reviews proposed changes, obtains additionalclarification/informationas necessary, and ensures that all relevant supporting documentation for a given change control is included.
Facilitates meetings to gain consensus between impact reviewers. Negotiates agreements on change conflict.
Assists Supervisor and Manager in identifying change control issues which need correction or improvement. Also assists Supervisor and Manager in preparing and/or conducting change control training, as required.
Reviews and tracks all change controls throughout the change control process utilizing TrackWise. Obtains additionalclarification/informationas necessary and provides pertinent feedback to change request initiators and management.
Review all risk assessments for completeness.
Perform the job duties of Document Control Specialist as requested.
B.A. or B.S. degree preferably in scientific or technical field (e.g., chemistry,biology, physics, engineering, computer science, technical writing) or experienceand training equivalent to such a degree.
Two or more years experience working in a cGMP regulated environment such asthe field of quality, manufacturing or engineering field, applying the cGMP rules ineveryday activities. Specific experience in the process of change control ispreferred.
Knowledge of cGMP’s and FDA guidelines required. Must demonstratecompetency in verbal and written communication. TrackWise and DCMScomputer application. Manufacturing process and FMEA Quality Risk Assessmentknowledge a plus.
State/Province : Illinois
City : Kankakee
Street Address : 1201 N. Kinzie
Primary Location : CSL Behring Kankakee
Full Time/Part Time : Full Time
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click below.
CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement