Job Description
Join to apply for the Instrumentation Quality Assurance (QA) role at MillenniumSoft Inc
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Join to apply for the Instrumentation Quality Assurance (QA) role at MillenniumSoft Inc
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
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Full-time
Job function
Job function
Management and Manufacturing -
Industries
Staffing and Recruiting
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Job Tags
Full time, Contract work, Work at office, Shift work, Afternoon shift,