Quality Specialist III, GXP Training

Quality Specialist III, GXP Training

Job Location: Coventry, RI / Stamford, CT/ Wilson, NC (flexibility on which site, Stamford is preferred)

Duration: Direct FTE Role

Client: Purdue Pharma

Write up on Quality training experience and managing and troubleshooting Cornerstone LMS as well as mention if Pharma experience or similar industry like medical devices.

Summary of Work:

The hiring manager is specifically looking for a candidate with quality training experience and who can manage and troubleshoot their current LMS, Cornerstone. Pharma experience would be a great plus or similar industry like medical devices.

Should have Learning Management System (LMS) experience and preferably with Cornerstone LMS.

Must have Pharmaceutical domain experience in recent employment.

Should have expertise in cGMP, Gxp and FDA Regulations.

The Quality Specialist III, GXP Training is required to support and enhance the quality training programs related to key compliance initiatives, applicable regulatory requirements, as well as local and global processes. Primary duties include administration of the Cornerstone Learning Management System, including but not limited to, curricula maintenance, data entry and assessment creation. In addition, the position evaluates existing 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, business units and site management to streamline/progress training needs.

Primary Responsibilities:

o Identifying, recommending, and implementing improvements to the training function to make it more effective and efficient in supporting business objectives and compliance requirements

o Facilitating the development of training curricula for US Sites

o Perform training needs analysis and effectiveness assessments and deliver programs as deemed appropriate. Coordinates/delivers other regulatory training as required.

o Ensuring training documentation is accurate and compliant with Good Documentation Practices

o Coordination with Training colleagues at all sites to develop and implement training programs to improve training effectiveness, current practices and optimize operations

o Establishing and maintaining industry contacts on current compliance and training issues by participation in external Training industry groups

o Proactively support company priority initiatives with activities that are outside planned responsibilities and objectives

o the maintenance of GXP training files, ensures GXP files are current and in compliance with regulations and internal procedures.

o Coordinates with LMS owner to provide training records as requested in support of external and internal audits.

o Provide Quality SME input on deviations, Laboratory Investigations, Planned Deviations, Change Controls and CAPAs,

o Provide training direction, analysis, and guidance to the US Sites regarding quality related compliance issues.

Education and Experience:

Quality Specialist III, GXP Training must have:

BS required for external candidates 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

Necessary Knowledge, Skills, and Abilities:

o A thorough understanding of cGMP and excellent working knowledge of FDA regulations Preferred certification in Instructional Design

o Preferred experience in managing LMS systems

o Experience in establishing training effectiveness programs

o Possess a strong ability to resolve and communicate technical issues, and perform root cause analysis

o Demonstrated ability to act as a functional expert

o Ability to negotiate needed actions and manage difficult interactions effectively.

o Knowledge of computerized support tools and training software