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Operator 2, Other Production 11 days ago
Location: San Diego, CA, USA

Job Code: 1031646

Mandatory / Primary Skills:

Experience with system databases such as SAP, CalMan and BMRAM are a plus

Job 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 BD 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. 
some additional daily duties 

Metrics generation and maintenance (SLA Metrics, Local Metrics & Corporate Metrics) 
Routine review of Asset record statuses to ensure timely processing of transactions by all approvers.
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