Instrumentation Quality Assurance (QA)

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