Quality Assurance Analyst Jobs

Job Details:

Job Title: QA Test Analyst II

Location: South San Francisco, CA 94080

Duration: 6+ Months (Contract To Possible)

Schedule Hours: 9:00-5:30 PST

100% onsite position, no remote workers. Facility, worker will be working in handles potentially infectious substances, but the worker will not directly be handling the substances, as the will be working in an office environment within the building.

Position Description:

The QA CSV Specialist is an integral member of the Quality department and will provide direct support in the management, maintenance and continuous improvement of Monogram’s Quality Management System (QMS), particularly in the Change Control system.

Primary Responsibilities:

·Management and maintenance of the IT Change Control System.

·Effective management of validation activities between cross-functional groups such as

·IT, user and business process owners, consultants and Quality.

·Design and preparation of test plans and test cases in collaboration with IT and user groups including key stakeholders and SMEs.

·Protocol execution, exception reporting, participating in exception analysis and resolution.

·Participation in the data specifications and format review/approval process for Pharma sponsors and similar clients.

·Participating in the IT change control indicators and metrics assembly and review.

·Assessment of computer-based laboratory instruments to determine software validation requirements.

·Participation in software project teams, defining validation requirements and when appropriate, provide compliance guidance for validation activities.

·Performing Equipment Qualification (IQ, OQ, PQ) on laboratory equipment and instrument.

·Maintenance of other Quality functions as designated by QA management.

Requirements:

·BS/BA in Information Technology/Computer Science, Biological or Clinical Laboratory or other related discipline

·4-6 years of experience with performing computer validations or related assignments.

·Previous experience in a regulated environment, preferably in Part 820 QSR, ISO 13485, GxP or CAP/CLIA.

·Ability to interact effectively with various departments: Research, Process Development, Support Operations, Customer Service, MCRL, IT, and Clinical Research.

·Excellent (written and verbal) communication and interpersonal skills, solid organizational skills, and ability to contribute to a collaborative, flexible work environment

·Strong documentation skills

·Technical understanding of clinical laboratory operations is a plus