Validation Specialist or Quality Rep - Biotech Resume Search
Validation Specialist or Quality Rep - Biotech Resume Search
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Validation Specialist or Quality Rep Resume


Desired Industry: Biotech SpiderID: 31677
Desired Job Location: Indianapolis, Indiana Date Posted: 12/17/2009
Type of Position: Full-Time Permanent Availability Date: 12/17/2009
Desired Wage: 52000
U.S. Work Authorization: Yes
Job Level: Experienced with over 2 years experience Willing to Travel: Yes, 50-75%
Highest Degree Attained: Bachelors Willing to Relocate: Undecided


Objective:
To Obtain a position as a Validation Engineer or Quality Rep


Experience:
Eli Lilly June 2008 - December 2009 Validation Engineer
Microsoft development project
Manage multiple projects to provide documented validation of equipment, control systems.
Write and Review department SOPs for content and compliance with regulatory requirements.
Analyze data associated with validation protocols.
Develop and review test plan, traceability matrices, scenario maps to ensure design requirements are met.
Develop and review functional requirements specifications.
Conduct periodic qualification evaluations to ensure equipment is qualified.
Develop validation protocols and associated summary reports.
Conduct design qualification for relevant process equipment and SOPs.
Assess risks involved in processing steps.
Develop and review validation requirements.
Work with validation teams to support and monitor efforts.
Ensure facility validation strategies and policies are followed.
Lead process validation projects.
Evaluate quality control data, change control requests (CCs) and validation documentation
Laboratory Information Management System (LIMS) database software. Regulus, Empower, Visio, Kiosk, Citrix, Lotus Notes, Snag-It, Velquest (Smartlab), Microsoft Word, Power Point, Excel, GMP experience.
strong analytical/problem solving and communication skills.

Pfizer Pharm 2004 - 2008 QA Rep
Participate in investigations and corrective action identification and implementation process for environmental and critical system excursions, OOS, OOT, and Exceptions.
Review the batch and analytical data generated by manufacturing.
Review various validation and technical documents to comply with regulatory requirements.
Monitor final batch disposition of manufactured products
Identify gaps and improvement opportunities within the quality system.
Review and approve SOPs for quality impact and compliance with regulations.
Perform technical and administrative review of batch and analytical data for accuracy and compliance with procedures.
Review and approve QC product testing documentation supporting batch release.
Develop operating procedures for the laboratory.
Write reports, business correspondence, and procedure manuals
Laboratory Information Management System (LIMS) database software. Regulus, Kiosk, Citrix, Trackwise, Lotus Notes, GMP experience.



Education:
Bachelor of Science in Chemistry
Associate of Science in Laboratory Medical Tech


Skills:
Manage multiple projects to provide documented validation of equipment, control systems.
Write and Review department SOPs for content and compliance with regulatory requirements.
Analyze data associated with validation protocols.
Develop and review test plan, traceability matrices, scenario maps to ensure design requirements are met.
Develop and review functional requirements specifications.
Conduct periodic qualification evaluations to ensure equipment is qualified.
Develop validation protocols and associated summary reports.
Conduct design qualification for relevant process equipment and SOPs.
Assess risks involved in processing steps.
Develop and review validation requirements.
Work with validation teams to support and monitor efforts.
Ensure facility validation strategies and policies are followed.
Lead process validation projects.
evaluate quality control data, change control requests (CCs) and validation documentation



Additional Information:
With my experience I feel I would be an asset to any company.


Reference:
Available upon request.


Candidate Contact Information:
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