Posting ID : A1068488244
Date Posted : 2015-08-18
Category : Science Biotech
The Quality Engineer is primarily responsible for validation activities at LGC Biosearch Technologies. 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, the Quality Engineer will be responsible for participating in failure investigations, performing risk assessment/analysis, analyzing process data and preparing trend analyses to further continuous improvement initiatives. This position reports to the Senior Manager, Quality Assurance.
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 nonconformances 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 setting specifications for raw-materials, in-process testing and final product release.
Assist in internal and external audits.
Act as back-up for QC Chemistry when necessary.
Other duties, as assigned.
B.S. Degree in Engineering, Chemistry, Biology or related field.
Minimum of 1 year work experience in a Quality Control or Quality Assurance role.
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.
Employees in this role may be called upon to work with Hazardous Materials and/or handle Hazardous Waste.
This position will be based out of LGC Biosearch's Novato location.
Benefits and Compensation:
LGC Biosearch is an equal-opportunity employer offering excellent health and retirement benefits and a competitive salary commensurate with experience.
Please send your cover letter and resume by responding only to this posting.