Sr. Validation Associate/IT Validation Analyst Resume

PROFESSIONAL EXPERIENCE

Confidential

Sr. Validation Associate/IT Validation Analyst

Responsibilities:

Develops validation plans for new computer systems including: familiarization of new systems, project timeline planning, interdepartmental communications with system owners and documented change control procedures in a pre - clinical pharmaceutical research setting (GLP).
Authors validation documentation for user requirements, installation qualifications, test script executions, and validation summary reports. Completes validation and change controls while maintaining compliance to 21 CFR Part 58, 21 CFR Part 11, and company standard operating procedures.
Engages in Sponsor audits from the Computer System Validation aspect.

Confidential

Quality Assurance Auditor

Responsibilities:

Quality Assurance department trainer responsible for training new employees on department procedures and GLP guidelines, mentoring trainees during inprocess inspections and audits, and reviewing data and report audits conducted by trainees.
Developed training matrix to better align with company training program.
Audited study specific laboratory functions, data, and reports to assure compliance with applicable federal regulations, customer protocols and site standard operating procedures (SOP).

Confidential

Quality Assurance Specialist

Responsibilities:

Responsible for administrating the day to day implementation and performance of the Quality Management System (QMS) including protocols, tools, and systems for the efficient monitoring, measuring, prevention, and correction of quality deviations.
Developed, implemented, communicated, and maintained a quality plan under the leadership of the Director of PBS Operations to bring the VARI/TGen Program for Biospecimen Science’s quality systems and policies into compliance with quality system requirements.

Confidential

Quality Assurance Validation Technician

Responsibilities:

Developed validation plans for new and legacy software systems including: familiarization of new systems, project timeline planning, interdepartmental communications with system owners and documented change control procedures in a consumer product testing setting (cGMP). Authored validation documentation for validation master plans, system risk assessments, and requirement specifications. Updated and developed existing computer software validation policies and procedures.

Confidential

Quality Assurance/Sr. Validation Associate

Responsibilities:

Audited study specific laboratory functions, data, and reports to assure compliance with applicable federal regulations, customer protocols and site standard operating procedures (SOP). Facilitated training of new auditors which included accompaniment on laboratory functions and second review of data and report audits for adherence to departmental procedures.
Application owner and system administrator of the QAAD audit software system: performed system configuration, development of user guides, provided training materials, created internal department processes, implemented training of employees, and assisted in the expansion of the systems use in multiple departments.
Developed validation plans for new computer systems including: familiarization of new systems, project timeline planning, interdepartmental communications with system owners and documented change control procedures in a pre-clinical pharmaceutical research setting (GLP).
Authored validation documentation for user requirements, installation qualifications, test script executions, and validation summary reports. Completed validation and change controls while maintaining compliance to 21 CFR Part 58, 21 CFR Part 11, and company standard operating procedures.