MILLENNIUMSOFT
Instrumentation Quality Assurance (QA)
MILLENNIUMSOFT, San Diego, California, United States, 92189
Position : Instrumentation Quality Assurance (QA)
Location : San Diego, CA
Duration : 1 Year Contract
Start Time : 07:30 AM
End Time : 04:00 PM
Total Hours/week : 40.00( Mon- Fri)
Qualifications:
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.
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.
Requires a current, valid, unrestricted California Driver's License and clean driving record.
Responsibilities:
Routinely reviews electronic and hard copy calibration, maintenance and repair records for accuracy and GDP (good documentation practices) compliance.
Routinely approves/ rejects completed work records providing input to technicians when records need correction/ additional information.
Routinely perform database management and maintenance to ensure accuracy and integrity of data.
Routinely review and approve/reject work requests submitted by end users and converts approved requests to into work orders.
Routinely assigns incoming work orders to technicians and communicates with end users and technicians.
Routinely generates weekly reports for work order tracking and reconciliation by supervisor
Routinely process OOT records and assigns work to equipment owner investigators, approvers and QA.
Update records in BMRAM with new/revised specification information
Assign new MDTs/ WPTs to equipment records in BMRAM
Review and approve work performed by regular and contract staff
Administer/support vendor services
Execute & complete training requirements as assigned by supervisor
Performs work in a manner consistent with Client quality policies and procedures to ensure compliance with quality and regulatory requirements
Positive can do attitude and performs duties as assigned by supervisor
Location : San Diego, CA
Duration : 1 Year Contract
Start Time : 07:30 AM
End Time : 04:00 PM
Total Hours/week : 40.00( Mon- Fri)
Qualifications:
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.
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.
Requires a current, valid, unrestricted California Driver's License and clean driving record.
Responsibilities:
Routinely reviews electronic and hard copy calibration, maintenance and repair records for accuracy and GDP (good documentation practices) compliance.
Routinely approves/ rejects completed work records providing input to technicians when records need correction/ additional information.
Routinely perform database management and maintenance to ensure accuracy and integrity of data.
Routinely review and approve/reject work requests submitted by end users and converts approved requests to into work orders.
Routinely assigns incoming work orders to technicians and communicates with end users and technicians.
Routinely generates weekly reports for work order tracking and reconciliation by supervisor
Routinely process OOT records and assigns work to equipment owner investigators, approvers and QA.
Update records in BMRAM with new/revised specification information
Assign new MDTs/ WPTs to equipment records in BMRAM
Review and approve work performed by regular and contract staff
Administer/support vendor services
Execute & complete training requirements as assigned by supervisor
Performs work in a manner consistent with Client quality policies and procedures to ensure compliance with quality and regulatory requirements
Positive can do attitude and performs duties as assigned by supervisor