Levi, Ray & Shoup, Inc. Laboratory Systems Validation Consultant in Waco, Texas

Looking for more than just another assignment? We're looking for you! This isn't just another assignment, but a real opportunity and a challenge for the right person. LRS Consulting Services is seeking a Laboratory Systems Validation Consultant for a 1-year contract opportunity with our client in Waco, TX!

LRS Consulting Services has been delivering the highest quality consultants to our clients since 1979. We've built a solid reputation for dealing with our clients and our consultants with honesty, integrity, and respect. We work hard every day to maintain that reputation, and we're very interested in candidates who can help us. If you're that candidate, this opportunity is made for you!

The Laboratory Systems Validation Consultant will:

  • Be responsible for performing duties related to computer systems validation project management. This includes attending status meetings, strategy meetings and other required meetings, as well as maintaining the validation timeline and status for validation projects.

  • Manage the activities of validation consultants utilized to assist in the implementations.

  • Develop and review validation documents and implementation documentation that supports required validation activities. Documents include Validation Project Plan, Requirements and specifications, vendor Evaluation Documentation, Installation/Operational/Performance Protocols and Final Reports.

  • Provide technical assistance, training and work direction to other staff members.

  • Write protocols that challenge the critical parameters related to installation, operation, and performance of the related chemistry and microbiology laboratory computer systems or equipment, and assure that protocols are approved through proper channels.

  • Research and recommend changes; write and revise validation protocols and procedures.

  • Execute validation and qualification protocols per related SOPs and assure that acceptance criterion related to validation and qualification protocols are met.

  • Interact with all affected personnel in the execution of protocols and gathering of test data. Ensure that all test data is gathered and recorded in accordance with cGxP requirements and industry trends.

  • Analyze data to ascertain that it meets related protocol acceptance criteria. Write deviation reports as required upon failures to meet protocol acceptance criteria.

  • Write final reports and ensure that they are approved through proper channels.

  • Develop and communicate project timeline and status.

  • Carry out responsibilities in accordance with the organization's policies and procedures, state, federal and local laws.

  • Perform related duties as assigned.

Requirements:

  • Bachelors degree in related field from an accredited college or university

  • 9+ years of progressively responsible related experience preferably within the food, cosmetic or pharmaceutical industries

  • Knowledge of management systems and enterprise-type systems

  • Current Good Laboratory Practices (cGLP), Food and Drug Administration (FDA), and related federal, state and local laws, codes, regulations and regulatory requirement

  • Experience validating global IT systems

  • Knowledge of Pharmaceutical quality control processes, principles, practices and applications

  • Familiarity with principles and practices of qualification and validation in accordance with USP 1058 and GAMP5

  • Knowledge of techniques of sampling, testing and measuring, and principles of mathematical and statistical computations

  • Experience with Microsoft applications (Word, Access, and Excel)

  • Candidate must be able to effectively communicate in English (written & verbal)

  • Corp to corp candidates will not be considered

LRS is an equal opportunity employer. Applicants for employment will receive consideration without unlawful discrimination based on race, color, religion, creed, national origin, sex, age, disability, marital status, gender identity, domestic partner status, sexual orientation, genetic information, citizenship status or protected veteran status.