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GLP Auditor (Memphis, TN)
By | July 9, 2009
We are currently recruiting for a professional GLP Auditor with a solid background and work history for a growing client of ours. This position is based in Memphis, Tennessee. The position we are seeking to fill is an immediate need
This is a great opportunity with a growing biopharmaceutical company that is focused on the development of oncology and critical care products. It is a position with great compensation, benefits, and relocation is provided for the right candidate.
Listed below are the main responsibilities and requirements for this position and what we are looking for in a candidate:
GLP Auditor:
The GLP Auditor will be responsible for performing internal GLP and related method validation audits as well as assisting in or performing other external QA activities.
Core Responsibilities
Perform quality system audits as they pertain to GLP regulations and guidances
Internal Study Audits:
Conduct reviews of validation study protocols and amendments and bioanalytical dose solution and sample analysis test plans and amendments
Conduct in-process audits on critical phases of the studies conducted. This includes data processing, solution preparation, and sample preparation
Perform audits on the data and documentation for the studies conducted (LC/MS, HPLC & PCR)
Conduct reviews of draft and final reports
Issue QA statements for all GLP studies
Maintain validation and GLP Study master Schedules
Generate written reports for each audit and when necessary conduct follow up audits
Conduct close-out meetings with respective study director/principal investigator after each audit.
External Study Audits:
Perform GLP vendor site qualification audits, follow-up visits, and routine requalification inspections as needed.
Review of vendor prepared protocols, amendments, and study reports
Prepare written reports, and evaluate corrective actions the observations noted.
Review draft final reports.
Issue a Conformance statement for these studies.
Other QA Responsibilities as Required:
Provide GLP and SOP training to Company personnel
Partner with functional areas to develop, maintain and approve SOPs
Review IND submissions (safety)
Review equipment IQ, OQ and PQ(s) and approve equipment for use.
Work with functional management on development of Individual Training Plans (ITP) for the respective areas based on job function
Introduce new employees to the training program and oversee the completion of their ITP
Ensure GLP training is conducted annually for applicable Company personnel
Support other QA functions in times of excessive workload. Will include the areas of Good Clinical Practice (GCP) and Computer System Validation. Appropriate cross-training must be completed to facilitate this support.
Develop new and revise/update existing GLP policies and procedures for the Quality System.
Track and review procedure deviations and laboratory investigations through resolution.
Preferred Qualifications:
Bachelors degree in a scientific field
2 to 5 years of experience in FDA regulated laboratory environment
Previous experience in Quality Assurance area or other regulated compliance experience
Working knowledge of GLPs (FDA 21 CFR Part 58 and OECD)
Demonstrated effective communication skills both written and verbal
Working knowledge of 21 CFR Part 11 and computer validation requirements
Knowledge of ICH guidelines and FDA regulations applicable to GCP
Ability to successfully prioritize and manage multiple tasks while adhering to specified deadlines
Meticulous record-keeping skills and ability to prepare clear and meaningful reports
Work effectively in a team environment and builds strong working relationships
Ability to travel periodically as required. Travel frequency of 20%
If you are interested in pursuing this great opportunity further, please email your CV/resume to: jbradberry@accordscientific.com
Topics: Raleigh-Durham PCR jobs |
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