167562,  Document Control Coordinator - CA -

Category: ADM
Job Title: Document Control Coordinator - CA
Region: CA-Bay Area
City: Fremont
State: CA
Rate: Up to $16.37 DOE
Duration: 10 MONTHS
Description: Chipton-Ross is seeking a Document Control Coordinator located in Fremont, CA

oFollow SOP's to meet compliance requirements for all document and QA activities.
oProcess changes through the Document change process.
oAdminister and maintain records.
oNumber issuance for validations, lab notebooks, and project files.
oManages the archiving process and inventory listings for on-site and offsite.
oReview document changes and provide effective communications of changes for site awareness and to facilitate training requirements and provide applicable site training.
oUpdate BOMs and Item Masters as needed.
oAdminister and maintain compliant periodic review scheduling and reporting.
oAdminister system updates to the document control system as required.
oCollaborate with departments to ensure QMS compliance and alignment of local SOP's as required with common Business Unit SOP's.
oGenerate weekly reports to trend data for improvements within the Document Management System
oStrategize within Quality and cross-departmentally to assess effectiveness of current document control processes and make recommendations for improvements

Desired Profile:
oScience or related degree.
oDemonstrated troubleshooting and problem-solving techniques.
oProven ability to work under tight deadlines and pressure in a composed manner.
oComfortable communicating with all levels of staff, including executives.
oStrong technical writing skills.
oEffective organization, communication, and team orientation skills.
oExperience in Quality roles (CAPA, NCARs, & Change Control).
oImplementation of an Electronic QMS database.

oWorking knowledge of US / EU regulations and guidelines, including 21 CFR Parts 820, ISO 13485, IVDD, and audits.
oKnowledge of computer applications and current software (Microsoft Excel, Outlook, Word, Access, and PLM/ERP system).

Accredited High School Diploma/GED and equivalent 3 - 5 years' of related experience in fast-paced office manufacturing environment

Accredited Associate's degree from accredited college/university or equivalent experience.


Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.

Mahta Eslami at
343 Main Street
El Segundo, CA 90245

Phone: (310) 414-7800 x220 or (800) 927-9318 x220

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