Quality Specialist III, GxP Training
Company: Cogent Infotech Corporation
Posted on: May 28, 2023
- Provide business administration support for the CSOD system for
the Wilson site, including assessment of quarterly system releases
vs. business needs.
- Support validation testing of system changes, upgrades from an
- Meet with business functions routinely to identify, recommend,
and implement improvements to the training function to make it more
effective and efficient in supporting business objectives and
compliance requirements. This should reflect industry best
- Facilitate the development/maintenance of training curricula
for the RTP and Wilson sites.
- Perform training needs analysis and effectiveness assessments
as deemed appropriate.
- Coordinates/delivers other regulatory training as
- Ensure training documentation is accurate and compliant with
Good Documentation Practices
- Coordinate with Training colleagues at the Stamford site to
develop and implement training programs to improve training
effectiveness, standardize practices and optimize operations
- Establish and maintain industry contacts on current compliance
and training issues by participation in external Training industry
- Proactively support company priority initiatives with
activities that are outside planned responsibilities and
- Maintain electronic and paper GXP training files, ensures files
are current and in compliance with regulations and internal
- Coordinate with LMS owner to provide training records as
requested in support of external and internal audits.
- Provide SME input on deviations, Laboratory Investigations,
Planned Deviations, Change Controls and CAPA.
- Provide training direction, analysis, and guidance regarding
quality related compliance.
Perform other related assignments and duties as required and
assigned.Education and Experience
- BS required and 4 years minimum relevant experience, or
equivalent level of experience in graduate degree (MS preferred)
with 2 years minimum relevant experienceNecessary Knowledge,
Skills, and Abilities
- A thorough understanding of cGMP and excellent working
knowledge of FDA regulations
- Experience in managing curricula in Cornerstone on Demand or
- Preferred experience in the creation of
Manufacturing/Laboratory On-boarding programs
- Experience in establishing training effectiveness programs
- A strong ability to resolve and communicate technical issues,
and perform root cause analysis
- Demonstrated ability to act as a functional expert and provide
input as such
- Ability to negotiate needed actions and manage difficult
interactions effectively.Knowledge of computerized support tools
and training software
Physical and Environmental Requirement
- Perform job functions in various positions that may require
sitting, stooping, balancing, kneeling, crouching, twisting, and/or
reaching. While sitting for an extended period of time on a routine
basis, incumbent may use the following equipment: Personal
computer, telephone/ other voice communication devices, copier,
fax, scanners, or other specialized equipment used in an office
- Ability to work a 10 hour per day/4-day work week; 40 hours per
week with overtime as required.
Keywords: Cogent Infotech Corporation, Wilson , Quality Specialist III, GxP Training, Other , Wilson, North Carolina
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