Quality Specialist III, GxP Training
Company: System One Holdings, LLC
Location: Wilson
Posted on: January 23, 2023
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Job Description:
Title: Quality Specialist III, GxP TrainingLocation: Wilson,
NCStart date: ASAPResponsibilities: The Quality Specialist III, GXP
Training is required to support and enhance the quality training
programs related to applicable regulatory requirements, as well as
local and global processes.Primary duties include business
administration of the Cornerstone on Demand (CSOD) Learning
Management System, including but not limited to, review and
assessment of quarterly release revisions, curricula maintenance,
data entry and reporting.In addition, the position evaluates
existing manufacturing training programs and data trends to
identify training needs and develop new training.This evaluation
assesses the adequacy of training materials and programs in a GxP
environment.Position will work closely with IT, manufacturing
business units and site management to streamline/progress training
needs.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 SME perspective.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
practices.Facilitate the development/maintenance of training
curricula for the sites.Perform training needs analysis and
effectiveness assessments as deemed
appropriate.Coordinates/delivers other regulatory training as
required.Ensure training documentation is accurate and compliant
with Good Documentation PracticesCoordinate 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 groups.Proactively support company priority
initiatives with activities that are outside planned
responsibilities and objectives.Maintain electronic and paper GXP
training files, ensures files are current and in compliance with
regulations and internal procedures.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. Requirements: BS required and 4
years minimum relevant experience, or equivalent level of
experience in pharmaceutical or related industries; or graduate
degree (MS preferred) with 2 years minimum relevant experienceA
thorough understanding of cGMP and excellent working knowledge of
FDA regulationsExperience in managing curricula in Cornerstone on
Demand or similar LMSPreferred experience in the creation of
Manufacturing/Laboratory On-boarding programsExperience in
establishing training effectiveness programsA strong ability to
resolve and communicate technical issues, and perform root cause
analysisDemonstrated ability to act as a functional expert and
provide input as suchAbility to negotiate needed actions and manage
difficult interactions effectively.Knowledge of computerized
support tools and training softwarePerform 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 setting. Ability to work a 10 hour per day/4-day work
week; 40 hours per week with overtime as required.
Keywords: System One Holdings, LLC, Wilson , Quality Specialist III, GxP Training, Other , Wilson, North Carolina
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