Quality Specialist III, GxP Training
Company: eTeam Inc.
Location: Wilson
Posted on: January 23, 2023
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Job Description:
Job title: Quality Specialist III, GxP Training
Location: Wilson, NC
Shift: 10 hour per day/4-day work week; 40 hours per week with
overtime as required.
Shift time: 9am to 5pm
Salary Range: Up to $85k salary
Education and Experience:
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
experience
Job Summary:
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.
Primary responsibilities:
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 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 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.
Necessary 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
similar LMS
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 Requirements:
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 setting.
Ability to work a 10 hour per day/4-day work week; 40 hours per
week with overtime as required.
Keywords: eTeam Inc., Wilson , Quality Specialist III, GxP Training, Other , Wilson, North Carolina
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