Quality Specialist III, GxP Training
Company: Axelon Services Corporation
Posted on: January 25, 2023
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.
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
- 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 required.
- 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
- 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
- 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
- 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
- Knowledge of computerized support tools and training
- 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
Keywords: Axelon Services Corporation, Wilson , Quality Specialist III, GxP Training, Other , Wilson, North Carolina
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