Job Description

This role supports the new Rapid Diagnostics Solutions (RDS) business unit in San Diego, California, part of the group of diagnostics businesses at Thermo Fisher Scientific. We are focused on increasing access to affordable innovations in diagnostic testing and enabling data-driven decisions. What we do matters because our work has a direct impact on people2019s lives, and we take that responsibility seriously.

Position Summary: The Quality Specialist II is a position to ensure that the Quality Management System at Mesa Biotech Inc. meet or exceed the internal/external customer expectations and compliance to standards. Responsible for developing and maintaining the required documentation that will meet or exceed ISO 13485 and cGMP requirements. In addition, the QA Specialist II will be responsible for ISO 13485 and FDA certification registrations under the guidance of outside consultants and management. This position will also be responsible for supporting internal/external audit processes.

Key Responsibilities:
2022 Create and maintain documentation required to meet or exceed QSR and ISO requirements
2022 Support the Quality Team during internal/external audits
2022 Maintains up to date knowledge of cGMP regulatory issues, industry and affiliated publications, standards, and guidance
2022 Develop and implement continuous improvement initiatives via data analysis of Quality KPIs and metrics
2022 Collect Quality metrics and facilitate Management Review
2022 Supports internal and external audits as needed
2022 Provide QA oversight for manufacturing and Quality System documentation including Batch Records, lot release, Change Orders, CAPA, NCRs, Deviations, etc.
2022 Compliance with established Company and departmental policies and procedures, objectives, quality assurance program, safety, and environmental standards
2022 Other duties as assigned as emerging growth company it may be required from time to time to assist in other areas other than the area of specialty

Minimum Requirements/Qualifications:
2022 Bachelor2019s Degree or equivalent experience plus a minimum of 4 years detailed oriented work experience in an FDA regulated and/or cGMP environment required

Personal attributes:
2022 Excellent knowledge of MS Office. MS Word skills required: Templates, styles, headers, working with cross referencing figures, tables, and sections
2022 Working knowledge of FDA, QSR, GMP, and ISO13485 is a plus
2022 Ability to work effectively as part of a cross functional team
2022 Ability to relate and work well with people
2022 Excellent organizational skills
2022 Excellent verbal/written communication skills 2022 Attention to detail 2022 Ability to multi-task and work well under pressure

Non-Negotiable Hiring Criteria:
2022 Experience in an FDA regulated and/or cGMP environment required