Phoenix - CC16 - Phoenix, AZRemote Type
Full TimeEducation Level
QA - Quality Control
The CSV Lead, GMP Systems will provide senior level expertise in the Computer System Validation and qualification program for laboratory instrumentation and systems. This role will drive the implementation and validation of VLMS software, author CSV deliverables and lead validation activities and support program improvement initiatives. The CSV Lead will drive complex validation projects across multiple functional areas, including all aspects of medical device manufacture in GMP environment. Job Responsibilities
- Author CSV and qualification deliverables for validation of laboratory instrumentation.
- Support and supervise validation execution activities including document authoring/approval, protocol review, handling of exceptions, root cause investigations, risk assessments and change control.
- Provide expert guidance in the implementation and validation of a software platform (SaaS) for validation lifecycle management
- Lead and support cross-functional projects and teams, including validation of laboratory related QMS support applications and digital pathology applications, support for laboratory database and LIS rollout, and validation planning across multiple functional facilities.
- Support CSV program scaleup and implementation across in all asset-managed environment.
- Ensure all applicable GMP and QMS requirements are met in production environment per 21 CFR Part 11, 21 CFR Part 820, ISO13485, ISO9001 and IVDR.
- Bachelor's degree in biological science, chemistry, engineering or related field.
- A minimum 5 years of experience working within an FDA regulated industry (Medical Device or Pharmaceutical) required.
- A minimum 2 years in a senior position with proven track record of successful team collaboration and project execution
- Demonstrated knowledge of 21 CFR Part 11, including ERES and predicate rule requirements and Data Integrity
- Demonstrated experience in Computer System Validation and qualification of complex computerized laboratory instrumentation.
- Strong knowledge of QMS requirements per ISO 13485 and 21 CFR Part 820.
- Proficient in GAMP5 principles, Risk-based approach to validation, Change Control and Root Cause investigations
- Conditions of Employment: Individuals must successfully complete pre-employment process, which includes criminal background check, drug screening, and reference verification. Also, individual must be fully vaccinated for COVID-19 by the date of hire to be considered for U.S.-based jobs, if not currently employed by Caris Life Sciences.
Core Skills & Competencies
- Training in GAMP5 principles and Computer System Validation
- Training in Root Cause Analysis, Risk Management and QMS requirements for Medical Device development.
- Competent in Quality System Regulation, GMP production, GAMP5 CSV and risk-based approaches
- Strong communication skills and team-building mindset
- Project Management skills to support cross-functional teams and complex projects
- Employee may be required to lift routine office supplies and use standard office equipment.
- Ability to stand or sit for extended periods of time.
- Majority of work is performed in a desk/cubicle and in the laboratory environment, which may include exposure to high noise levels in the various areas, (e.g., laboratory, warehouse)
- All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
- This position requires periodic travel and some evenings, weekends and/or holidays.
This job description reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
*Interested parties please email your resume to Tonia Hunter @ firstname.lastname@example.org. #LI-TH1