Biotech-Pharmaceutical Industry
Senior Quality Management Systems Engineer
Expanding biotech in the San Diego area is looking for Senior QMS Engineer with
Summary:
Expanding Biotech looking for a Senior Quality Engineer with strong MasterControl experience to provide high level technical quality engineering support and development of the Quality Management System, Training and other Quality related applications.
Responsibilities include the following:
- Strong experience and able to create and maintain system user groups, roles, workflows and curriculums in MasterControl.
- Able to create software and potential hardware modifications to the system(s) using Software Development Life Cycle (SDLC) best practices in conjunction with established Change Control policies.
- Responsible for testing, assisting and executing validation test scripts in MasterControl.
- Will create and maintain reports in MasterControl and Compliance Wire and other systems.
- Work with department teams to gather necessary requirements for maintaining MasterControl and Compliance Wire as needed.
- Ability to create and maintain operational procedures relevant to the applications and trains the departments as necessary with respect to any changes.
- Maintain application knowledge, including staying current on software capabilities and availability of new functionality and updates from the software vendor.
- Assist, maintain, and update the test protocols, creating and maintaining Quality Matrix.
- Author, review and revise QMS policies and procedures.
- Participate in internal and external audits as required.
- Act as the point of contact for technical support, ensuring accuracy and completeness of data; implement improvements; establish and maintain security and integrity controls.
- Engage and work with application software vendors and consultants to further configure the system, deploy functional enhancements and correct configuration issues.
- Provide incident diagnosis and support business users in the management and timely resolution of technical incidents.
Required:
- BS/BA degree in Computer Science, Information Technology or equivalent discipline required.
- 8 Years relevant experience with Quality Assurance & Quality Systems required.
- 5 Years of Quality Systems experience required; Master Control experience preferred
- Experience in the pharmaceutical or biotechnology industry preferred.
- Knowledge of GxP, FDA regulations, 21 CFR Part 11, 210, 211 and 820 compliances, familiarity with GxP best practices and GMP Compliant Change Control process.
- Must possess strong knowledge of systems development life cycle, application development or systems integration.
- Knowledge of SQL, JQuery and Crystal Reports desirable.
- At least 3 years recent or current Pharmaceutical or Biotechnology industry experience