Title – Training Program Specialist
Location: Marlborough, MA 01752
Duration: 6 Months (temp to perm)
Description:
Required skill set – Bachelor’s degree or high school diploma / GED plus 4 years experience in a regulated industry training or training related position. Strong working knowledge of English language (written and oral). Experienced with Microsoft Office products (Word, PowerPoint) and Excel.
Is this a temp to perm position – Yes, we anticipate that this position will become a permanent need.
This is a potential temp to perm position for the right candidate. Please ask your candidate(s) if they are legally authorized to work for any employer in the US without sponsorship and ensure the question is answered/confirmed in the comments when you submit the candidate(s). Thank you!
Job Description:
Role Summary:
Responsible for contributing to the efforts of the Locke Drive Site Operations and QA teams by establishing and driving processes for the creation of, instruction of, and documentation of training used to support current Good Manufacturing Practices (cGMP) at a biological manufacturing site.
Essential Responsibilities:
• Evaluate to gain an understanding of the current training program and related training documentation systems.
• Gather and assess current training materials, assess current training approaches for new and existing employees, manage trainee lists, and ownership of training plans and materials.
• Work with site team members to create training matrices specific to each core team (i.e., Manufacturing, QC Laboratory, Warehouse, QA, etc.)
• Utilizing training matrices, create or update related courses for documenting training in MasterControl, the site’s document and training management system.
• Develop and implement training checklists and competency check forms that can be used to assess and document the on-the-job (OJT) training provided.
• Develop a process for evaluating and designating staff as Subject Matter Experts (SMEs) or subject matter trainers.
• Once enhanced processes and related training forms are created, update related standard operating procedures (SOPs) or create new SOPs as needed to define the training program.
• Schedule and coordinate periodic (quarterly) site newcomer orientation and refresher training days.
• Develop, collect, and present training metrics data at the Quarterly Management Review (QMR) meeting to show the state of site training.
Required Qualifications:
• Bachelor’s degree or high school diploma / GED plus 4 years experience in a regulated industry training or training related position.
• Strong working knowledge of English language (written and oral).
• Experienced with Microsoft Office products (Word, PowerPoint) and Excel.
Desired Characteristics:
• Strong knowledge of pharmaceutical regulations or guidelines (FDA, ICH).
• Coursework in Training, Quality Assurance, or Regulatory Affairs.
• Strong process improvement mindset.
• Familiar with electronic data management systems. Prior experience with MasterControl a plus.
• Demonstrated interpersonal and teamwork skills.
• Excellent oral and written communication skills.