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|Job Category :
||Document Control and management
||San Diego, CA
|Job Description :
We work as trusted business partners and always strive to deliver the most value and highest return on investment for our clients. We are highly trained business professionals with strong understanding of clients need. We work closely with the leading staffing trade associations, training, and research organizations to ensure we are knowledgeable of the latest industry trends and technologies.
The Document Control Analyst facilitates the Change Control process for in the electronic change control system as well as tracks the change process through development, approval, and implementation.Analyzes and interprets the significance of the proposed changes using independent judgment to guide change initiators in the development of accurate change requests.Reviews standard operating procedures, logs, forms, manufacturing records, work instructions and all other Quality records for adherence to established templates, good documentation practices and adequacy of referenced procedures and part numbers.Communicates issues effectively and partners with cross-functional associates to meet compliance requirements.Receives, classifies, files, audits, tracks and maintains centralized documentation archiving system.Collects and enters data for the creation of metrics and reports for various departmental activities.Exercises good judgment and uses decision making skills to effectively perform job responsibilities.Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies.Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.Perform other duties & projects as assigned.
MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:
High School DiplomaIntermediate knowledge of Microsoft Word, Excel and Microsoft Access.2-4 years of experience preferably in an FDA regulated facility.
PREFERRED QUALIFICATIONS:Preferred experiential background:Must be able to work under minimum supervisionMust possess excellent communication skills, both verbal and writtenAbility to handle multiple projects simultaneously and to prioritize tasksWorks well with others in a team environmentKnowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDRDemonstrate problem-solving and troubleshooting skillsOrganized and detail oriented
COMPETENCIES:Acts ethically and takes accountability for achieving outcomes.Actively develops a network to bring best solutions to the team or customer.
Thanks and Regards,
PH – 229-264-4029
All your information will be kept confidential according to EEO guidelines.
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