Quality Assurance Validation Engineer
- Novato, CA
- Closing Date:
- 31 Dec 2017
LGC provides a range of measurement products and services which underpin the safety, health and security of the public, including reference materials and proficiency testing, genomics solutions, services and instrumentation, and expert sample analysis and interpretation. Our customers are across a number of end markets including Pharmaceuticals, Agricultural Biotechnology, Food, Environment, Government and Academia.
This role is primarily responsible for validation activities. Duties include development, implementation and performance of Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Process Validation (VP) protocols and drafting related Validation Reports (VR) in a regulated environment. Furthermore, they will be responsible for participating in failure investigations, performing risk assessment/analysis, analyzing process data and preparing trend analyses to further continuous improvement initiatives.
• Independently develop, implement and perform equipment IQ/OQ/PQ protocols
• Prepare Validation Reports
• Establish the Validation Master Plan and ensure that periodic revalidation activities occur for critical process equipment to ensure compliance with regulatory requirements in the GMP and Commercial Services production and Quality Control groups
• Perform or participate in failure investigations for non-conformances using standard Quality Improvement tools, prepare fishbone diagrams, perform root-cause analysis and provide recommendations to management
• Perform risk analysis/assessment of critical processes using Failure Modes and Effects Analysis (FMEA)
• Assist in the development, review and approval of Test Method Validation protocols.
• Analyze process data and perform trend analyses on critical processes to facilitate continuous improvement
• Work with management to improve Quality System policies and procedures
• Assist in internal and external audits
• Other duties, as assigned
Skills and Abilities:
• Strong technical aptitude for the understanding of process instrumentation/equipment.
• Excellent problem solving and analytical skills.
• Knowledge of applying statistical techniques and design of experiments preferred.
• Knowledge of FDA QSR, ISO 9001, ISO 13485 strongly desired.
• Effective interpersonal and communication skills in technical writing and capable of supporting cross-functional projects.
• Capable of multitasking and prioritizing several projects independently.
• B.S. Degree in Engineering, Chemistry, Biology or related field.
• Minimum of 1 year of work experience in a Quality Control or Quality Assurance role.
Essential competencies and behaviors:
• Resonates and operates in line with LGC’s core value behaviors: Respect, Integrity, Passion, Curiosity and Brilliance
LGC Biosearch Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, age, status as a protected veteran, or status as a qualified individual with disability.
To apply, please use the following URL: https://workforcenow.adp.com/jobs/apply/posting.html?client=LGCBTI&jobId=185720&lang=en_US&source=CC3