GLP Training Specialist
Actalent, Raleigh, NC, United States
Overview
The GLP Training Specialist develops, delivers, and maintains comprehensive laboratory training programs to ensure full compliance with Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), data integrity, and safety requirements in a regulated pharmaceutical environment. This role supports approximately 56 microbiology and chemistry laboratory personnel through hands-on, classroom, and on-the-floor training, with a focus on building a robust training framework for a new microbiology lab as well as several existing labs. The specialist serves as a subject matter expert for GLP training, ensuring staff apply procedures correctly, maintain high documentation standards, and remain inspection-ready at all times. Responsibilities
Develop, deliver, and maintain GLP- and GMP-compliant training programs for microbiology and analytical chemistry laboratory personnel. Ensure all training content aligns with FDA expectations, GLP, GMP, internal standard operating procedures (SOPs), and data integrity principles such as ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate). Serve as a subject matter expert for GLP training requirements within a regulated laboratory setting. Conduct hands-on and classroom training sessions for microbiology and chemistry staff, covering both fundamental and advanced laboratory practices. Deliver and reinforce training on 5S and laboratory housekeeping standards, ensuring a clean, organized, and efficient lab environment. Provide training on basic GMP and GLP principles, emphasizing data integrity and good documentation practices (GDP). Train staff on laboratory safety and environmental, health, and safety (EHS) fundamentals, including lab housekeeping and safe work practices. Deliver training in core microbiology laboratory practices, including routine techniques and workflows relevant to quality control and testing. Provide training in analytical chemistry laboratory practices, including key procedures, instrumentation use, and documentation requirements. Offer on-the-floor coaching and real-time feedback to ensure correct application of procedures and adherence to good documentation practices. Maintain accurate, complete, and audit-ready training records in accordance with GLP/GMP requirements and internal quality standards. Support development and maintenance of training matrices, tracking initial, refresher, and remedial training for all relevant laboratory roles. Partner with Quality, Laboratory Management, QC, QA, and EHS teams to identify training gaps and define appropriate corrective and preventive actions. Support regulatory inspections by providing training documentation, explaining training processes, and responding to auditor questions related to training and competence. Collaborate with QC, QA, EHS, and laboratory leadership to update training materials when procedures, regulations, or laboratory processes change. Support onboarding and re-training initiatives for new hires and existing staff, ensuring consistent and standardized training across all labs. Assist with investigations and CAPAs related to training deficiencies, helping to identify root causes and implement sustainable training solutions. Contribute to the implementation and sustainment of 5S programs within the laboratory environment. Help establish and refine training programs for a new microbiology lab while also supporting training needs in four existing laboratories. Essential Skills
Bachelor’s degree in Biology, Chemistry, Microbiology, or a related scientific discipline, or equivalent experience. 3–5+ years of experience working in a GLP, GMP, or regulated pharmaceutical laboratory environment. Demonstrated experience delivering laboratory training to scientific staff in a regulated setting. Working knowledge of microbiology and analytical chemistry laboratory operations and workflows. Strong understanding of GLP and GMP requirements, including data integrity and good documentation practices (GDP). Ability to clearly communicate technical and regulatory concepts to diverse laboratory audiences with varying levels of experience. Excellent organizational skills, with the ability to manage multiple training programs, schedules, and records simultaneously. Strong documentation skills to create and maintain accurate, audit-ready training materials and records. Effective presentation and facilitation skills for both group training sessions and one-on-one coaching. Comfort training groups and providing individualized coaching in an active laboratory setting. General experience with GLP laboratory safety, including enforcing lab safety and housekeeping practices. Additional Skills & Qualifications
Prior experience in a training-focused role within quality control (QC), quality assurance (QA), or laboratory operations. Experience supporting regulatory inspections by agencies such as the FDA or equivalent regulatory bodies. Familiarity with electronic training systems, learning management systems (LMS), or other training tracking tools. Experience implementing or sustaining 5S programs in laboratory environments. Experience in training development, including designing curricula, training modules, and competency assessments. Knowledge and application of ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate) for data integrity. Ability to enforce lab housekeeping and safety standards consistently across multiple labs. Interest in contributing to the growth of a new microbiology lab while supporting established laboratory operations. Work Environment
This role is fully on-site in a laboratory setting within a DEA- and GMP-controlled pharmaceutical environment. The GLP Training Specialist works primarily during normal business hours but needs to be available on certain days to support and train night shift personnel as needed. The position is based in active microbiology and analytical chemistry lab spaces, collaborating closely with QC, QA, EHS, and laboratory leadership. The work involves frequent presence on the lab floor to deliver hands-on training and coaching in real time. The environment emphasizes strong safety culture, strict adherence to GLP/GMP, 5S, and data integrity, and offers the opportunity to help build out training programs for a new microbiology lab as well as several existing laboratories. Job Type & Location
This is a Contract to Hire position based out of Wilson, NC. Pay and Benefits
The pay range for this position is $40.00 - $50.00/hr. Requirements
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Note:
Diversity, Equity & Inclusion and About Actalent sections were removed to maintain a focused job description.
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The GLP Training Specialist develops, delivers, and maintains comprehensive laboratory training programs to ensure full compliance with Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), data integrity, and safety requirements in a regulated pharmaceutical environment. This role supports approximately 56 microbiology and chemistry laboratory personnel through hands-on, classroom, and on-the-floor training, with a focus on building a robust training framework for a new microbiology lab as well as several existing labs. The specialist serves as a subject matter expert for GLP training, ensuring staff apply procedures correctly, maintain high documentation standards, and remain inspection-ready at all times. Responsibilities
Develop, deliver, and maintain GLP- and GMP-compliant training programs for microbiology and analytical chemistry laboratory personnel. Ensure all training content aligns with FDA expectations, GLP, GMP, internal standard operating procedures (SOPs), and data integrity principles such as ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate). Serve as a subject matter expert for GLP training requirements within a regulated laboratory setting. Conduct hands-on and classroom training sessions for microbiology and chemistry staff, covering both fundamental and advanced laboratory practices. Deliver and reinforce training on 5S and laboratory housekeeping standards, ensuring a clean, organized, and efficient lab environment. Provide training on basic GMP and GLP principles, emphasizing data integrity and good documentation practices (GDP). Train staff on laboratory safety and environmental, health, and safety (EHS) fundamentals, including lab housekeeping and safe work practices. Deliver training in core microbiology laboratory practices, including routine techniques and workflows relevant to quality control and testing. Provide training in analytical chemistry laboratory practices, including key procedures, instrumentation use, and documentation requirements. Offer on-the-floor coaching and real-time feedback to ensure correct application of procedures and adherence to good documentation practices. Maintain accurate, complete, and audit-ready training records in accordance with GLP/GMP requirements and internal quality standards. Support development and maintenance of training matrices, tracking initial, refresher, and remedial training for all relevant laboratory roles. Partner with Quality, Laboratory Management, QC, QA, and EHS teams to identify training gaps and define appropriate corrective and preventive actions. Support regulatory inspections by providing training documentation, explaining training processes, and responding to auditor questions related to training and competence. Collaborate with QC, QA, EHS, and laboratory leadership to update training materials when procedures, regulations, or laboratory processes change. Support onboarding and re-training initiatives for new hires and existing staff, ensuring consistent and standardized training across all labs. Assist with investigations and CAPAs related to training deficiencies, helping to identify root causes and implement sustainable training solutions. Contribute to the implementation and sustainment of 5S programs within the laboratory environment. Help establish and refine training programs for a new microbiology lab while also supporting training needs in four existing laboratories. Essential Skills
Bachelor’s degree in Biology, Chemistry, Microbiology, or a related scientific discipline, or equivalent experience. 3–5+ years of experience working in a GLP, GMP, or regulated pharmaceutical laboratory environment. Demonstrated experience delivering laboratory training to scientific staff in a regulated setting. Working knowledge of microbiology and analytical chemistry laboratory operations and workflows. Strong understanding of GLP and GMP requirements, including data integrity and good documentation practices (GDP). Ability to clearly communicate technical and regulatory concepts to diverse laboratory audiences with varying levels of experience. Excellent organizational skills, with the ability to manage multiple training programs, schedules, and records simultaneously. Strong documentation skills to create and maintain accurate, audit-ready training materials and records. Effective presentation and facilitation skills for both group training sessions and one-on-one coaching. Comfort training groups and providing individualized coaching in an active laboratory setting. General experience with GLP laboratory safety, including enforcing lab safety and housekeeping practices. Additional Skills & Qualifications
Prior experience in a training-focused role within quality control (QC), quality assurance (QA), or laboratory operations. Experience supporting regulatory inspections by agencies such as the FDA or equivalent regulatory bodies. Familiarity with electronic training systems, learning management systems (LMS), or other training tracking tools. Experience implementing or sustaining 5S programs in laboratory environments. Experience in training development, including designing curricula, training modules, and competency assessments. Knowledge and application of ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate) for data integrity. Ability to enforce lab housekeeping and safety standards consistently across multiple labs. Interest in contributing to the growth of a new microbiology lab while supporting established laboratory operations. Work Environment
This role is fully on-site in a laboratory setting within a DEA- and GMP-controlled pharmaceutical environment. The GLP Training Specialist works primarily during normal business hours but needs to be available on certain days to support and train night shift personnel as needed. The position is based in active microbiology and analytical chemistry lab spaces, collaborating closely with QC, QA, EHS, and laboratory leadership. The work involves frequent presence on the lab floor to deliver hands-on training and coaching in real time. The environment emphasizes strong safety culture, strict adherence to GLP/GMP, 5S, and data integrity, and offers the opportunity to help build out training programs for a new microbiology lab as well as several existing laboratories. Job Type & Location
This is a Contract to Hire position based out of Wilson, NC. Pay and Benefits
The pay range for this position is $40.00 - $50.00/hr. Requirements
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Note:
Diversity, Equity & Inclusion and About Actalent sections were removed to maintain a focused job description.
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