Quality Specialist III, GxP Training
Company: Katalyst Healthcares & Life Sciences
Location: Wilson
Posted on: May 26, 2023
Job Description:
Job Description
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. 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 experience
- 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
- 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
- bility to negotiate needed actions and manage difficult
interactions effectively.
- Knowledge of computerized support tools and training
software
- 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.
- bility to work a 10 hour per day/4-day work week; 40 hours per
week with overtime as required.
Keywords: Katalyst Healthcares & Life Sciences, Wilson , Quality Specialist III, GxP Training, Other , Wilson, North Carolina
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