GMP QA Training Specialist
Infrastructure & Support Philadelphia, PA
Contract Feb 16, 2024
Infrastructure & Support
QA Training Specialist
100% Remote
6-month contract – high likelihood of extension!!
Overview:
Our client, a pharmaceutical company in Philadelphia, is seeking a Good Manufacturing Practice QA Training Specialist to join their team! This is a long term contract opportunity with an initial duration of 6 months. This position is 100% remote. Candidates must work EST hours.
Summary:
The GMP QA Training Specialist is responsible for maintaining training programs for personnel engaged in GMP operations, ensuring compliance with US and international guidelines. This person will be involved assisting with training for new hires and contractors, collaborating with training coordinators to update GMP training requirements, maintaining training records, drafting materials for annual GMP training, and contributing to inspection readiness. The role also includes generating/updating computer-based training (CBTs) and ensuring current CVs and job descriptions are on file. Proficiency in ComplianceWire, excellent communication skills, and the ability to work collaboratively in cross-functional teams are essential.
Primary Duties
GMP QA Training Specialist will maintain training programs for personnel involved in GMP operations. These training programs will be compliant with US and international guidelines and requirements. Responsibilities include:
In addition other assignments will be added as needed to assure compliance
Education and Experience Requirements:
Preferred Requirements:
Must Haves:
#LI-REMOTE
#LI-QH1
100% Remote
6-month contract – high likelihood of extension!!
Overview:
Our client, a pharmaceutical company in Philadelphia, is seeking a Good Manufacturing Practice QA Training Specialist to join their team! This is a long term contract opportunity with an initial duration of 6 months. This position is 100% remote. Candidates must work EST hours.
Summary:
The GMP QA Training Specialist is responsible for maintaining training programs for personnel engaged in GMP operations, ensuring compliance with US and international guidelines. This person will be involved assisting with training for new hires and contractors, collaborating with training coordinators to update GMP training requirements, maintaining training records, drafting materials for annual GMP training, and contributing to inspection readiness. The role also includes generating/updating computer-based training (CBTs) and ensuring current CVs and job descriptions are on file. Proficiency in ComplianceWire, excellent communication skills, and the ability to work collaboratively in cross-functional teams are essential.
Primary Duties
GMP QA Training Specialist will maintain training programs for personnel involved in GMP operations. These training programs will be compliant with US and international guidelines and requirements. Responsibilities include:
- Assist with training requirements for newly hired FTEs and contractors
- Collaborate with training coordinators to update GMP training requirements to include position-based curriculum, update curriculum in ComplianceWire and monitor/track FTE training status by sending periodic training status reports to address non-compliances.
- Maintain training records files for GMP FTEs and contractors (paper and electronic).
- Draft training materials for annual GMP training.
- Assist in inspection readiness.
- Generate and/or update CBTs
- Ensure CVs and JDs) are current and on file
In addition other assignments will be added as needed to assure compliance
Education and Experience Requirements:
- Bachelor’s degree in Chemistry, Biology or a related scientific discipline, or equivalent Education or Training work experience
- 1-3 years of experience in GMP training the biotech/biopharma industry with working knowledge of GMP training requirements regulations. Experience with ComplianceWire business administration.
- Excellent written and verbal communication skills
- Quick learner, flexible and be able to multitask
- Problem-solving skills
- Ability to work with cross functional teams
Preferred Requirements:
- Experience working with Microsoft software applications for development of training tools
Must Haves:
- Must have ComplianceWire experience, similar tool will be considered but not ideal.
- Must have strong experience working with GMP (Good Manufacturing Practices) and understanding GMP Best Practices
- Prior training experience or acting as a GMP Subject Matter Expert
#LI-REMOTE
#LI-QH1