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Change Control Specialist

Randstad is seeking a Change Control Specialist for our client, a biotechnology facility in Bradley, Illinois. This position is part of the Change Management group and provides quality oversight for all changes associated with facilities, equipment, systems processes and materials while ensuring compliance with CSL procedures and cGMPs.
Responsibilities:
- 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.
- Evaluates change for completeness and issues approval for change.
- Participates in project teams.
- Communicates and coordinates with representatives of Manufacturing, Validation, Regulatory, Engineering, Compliance and other site personnel.
- Reviews proposed changes, obtains additional clarification/information as necessary, and ensures that all relevant supporting documentation for a given change control is included.
- Facilitates meetings and negotiates agreements on change conflict.
- Reviews and tracks all change controls throughout the change control process utilizing TrackWise.
- Review all risk assessments for completeness.
Working hours: 7 AM - 4 PM
Skills:
- TrackWise and DCMS computer application experience is a plus.
- Manufacturing process and FMEA Quality Risk Assessment knowledge a plus.
- Background in Quality or Validation is preferred.
- Project Management experience is a plus.
Qualifications:
- B.A. or B.S. degree preferably in scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science, technical writing) or experience and training equivalent to such a degree.
- Two or more years??? experience working in a cGMP regulated environment such as the field of quality, manufacturing or engineering field, applying the cGMP rules in everyday activities.
- Specific experience in the process of change control is preferred.
- Knowledge of cGMP???s and FDA guidelines required.
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.


Salary: $31 - 36 per hour + none




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