- 188600 - Quality Engineer III
- CA-Southern California - San Diego
- Up to $80.27 DOE
- 6 Months
- Chipton-Ross is seeking a Quality Engineer III for an opening in Carlsbad, CA.
The Computer Systems Validation (CSV) Lead will design and manage compliance activities for the assigned GxP regulated computerized systems throughout each system's lifecycle. This responsibility includes ensuring compliance with regulatory requirements, company Computer Systems Validation(CSV) and system lifecycle procedures and data integrity requirements.
The CSV Lead will contribute to MMS growth and expansion by:
Reviewing current processes, procedures and policies and recommend improvements to ensure compliance with regulatory requirements, including leading or participating in cross functional process improvement initiatives.
Leverage the individual's experience of industry trends to shape the future of CSV at MMS.
Being an resolutions focused and a key IT contact point for quality related issues.
What will you do?
In addition to the above, the CSV lead's duties include:
Development and approval of validation documentation, including system lifecycle documentation, test scripts, validation plans and summary reports
Through a risk-based approach, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems
Lead or perform periodic reviews of computerized systems
Lead or support the development of procedures, work instructions, validation templates and training materials to ensure that the control of GxP computerized systems is integrated into Quality Management System
Initial point of contact for client audits and regulatory inspections. Lead IT responses to inquiries arising from audits or inspections
Provide support in other quality system related activities including quality exceptions and change control
Minimally 6+ years’ experience with CSV in a life sciences, biotech or pharmaceutical company required, including GAMP5 and solid understanding of GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity
Knowledge of the computerized system lifecycle activities, CSV and IT controls in a regulated environment
Excellent organizational skills and attention to detail and accuracy
Experience supporting health authority inspections a plus
Experience successfully coordinating and navigating complex issues with internal and external stakeholders
Proven ability to successfully coordinate new quality initiatives while managing daily responsibilities
Ability to positively motivate and influence team members without line-management authority
Excellent communication, analytical, and organizational skills, using modern technology platforms
Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
Ability to draft and implement procedures, work instructions, and appropriate procedures for CSV
Accredited BA/BS required in Life Sciences, IT related discipline or equivalent experience with 6-7+ years of appropriate work experience preferred. Less experience 5+ required with a Master’s degree
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.