Job Listing Description

Change Control Analyst - CA

Chipton-Ross is seeking a Change Control Analyst for an opening in Fremont, CA.

Ability to maintain confidential information, to meet deadlines, manage priorities, accuracy and attention to detail is critical.
Assure that change records are readily retrievable and in inspection-ready condition.
Checks and verifies that change orders are accurate, properly cross reference all affected documents, and meet requirements for compliance with external customers, internal documentation and cGMP documentation practices.
Demonstrated proficiency level with Microsoft Office products required.
Demonstrates understanding of Quality Systems fundamentals, Electronic Quality Systems Management Systems (eQMS) (preferably MasterControl);
Demonstrates knowledge of the process, effects, and the relationship between the change process and products, and understanding of current Medical Device industry and applicable regulations including 21CFR820, ISO 13485, ISO 14971;
Coordinates sending out task emails, scheduling preproduction meetings between Engineering and Production, Marketing, QA, QC and submitting of Change orders for approval;
Supports the correct and timely implementation of Change Requests;
Participates as required in training on issues affecting own area of work. Notifies manager of compliance questions and issues;
Provides support to internal and regulatory audits/inspections as required.

MS with 0-2 years of experience in the medical device, biopharmaceutical/pharmaceutical or a related industry.
Ability to convince and influence others.
Good written and verbal communication skills.
This position requires at least one year experience in the administration of the change control process.

BS Degree or equivalent with minimum of 1 to 4 years of experience in change control administration.

1st Shift

Job Number: 169054
Job Location: Fremont, CA
Rate: Up to $28.63 DOE
Duration: 4 Months
Input Date: 05/09/2018
Attention: Rochelle Anderson
Address: 343 MAIN ST
City, State: EL SEGUNDO, CA 90245
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808

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