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MANUFACTURING OPERATOR
Ref No.: 18-04924
Location: San Diego, California
Start Date: 11/01/2018
Description
• Must have good project management, time management and organizational skills.
• Will routinely review, approve and coordinate all laboratory equipment related requests.
• Requires routine review and approval of event records including Calibration, Maintenance, and Repair records for accuracy, compliance and completeness.
• Routinely reviews and approves all new asset entries for conformance and data integrity to include accuracy and completeness of equipment records.
• Ideally possess a strong working knowledge and understanding of calibration and electronics terminology including calibration principles and specifications.
• Must be able to read, understand and work from technical manuals and S.O.P's.
• Must possess exceptional technical writing skills, critical thinking and data analysis skills to be able to develop, review & revise quality documents as required.
• Must have the ability to execute moderate to complex projects with limited supervision.
• Represents the department in a professional and positive manner to internal and external customers, vendors, and other groups within the company at all levels.
• Performs basic record keeping and data management activities such as entering equipment history records, running reports, and verification of data entered.
• Moderate to expert level experience with Microsoft Office tools such as Word, PowerPoint and Excel is required.
• Experience with system databases such as SAP, CalMan and BMRAM are a plus
• Requires the performance of all assigned duties in a manner consistent with Client and Departmental policies and requirements.
• Will be required to work independently within a team environment.

Qualifications External:
  • Minimum of 3 to 7 years of related experience working in a laboratory or quality related role is required.
  • Minimum of 5 years direct experience with ISO 9001:2008, 10012, 17025 or 13485 required.
  • Requires a strong working knowledge of good documentation practices in a regulated environment.
  • Knowledge of Refrigeration Equipment Calibration, Maintenance, Repair, and Troubleshooting is a plus.
  • Candidates must have the ability to effectively perform detailed review of quality documentation including data analysis.
  • Candidates must have the ability to effectively manage multiple tasks, shifts in priorities, and time sensitive projects.
  • Candidates must be customer service oriented. Must possess and be able to demonstrate a moderate to expert level understanding of Good Documentation Practices.
  • Must be able to understand technical terminology and be able to effectively use computer and database tools are required.