Job Title: Specialist Training Development
Duration: 06 Months-Contract
Location: 50% Onsite – Devens, MA
Pay Rate: $31.47/hr (W2)
Work Schedule: Monday – Friday | Normal Business Hours
Flexibility: Must be available to occasionally support 2nd or 3rd shift once per month (1–2 hours) to provide training.
Position Overview
- The Quality Training Coordinator (Contractor) will support the Quality organization by administering and maintaining training program activities in alignment with Devens Biologics Quality System requirements. This role partners closely with QA Operations and cross-functional teams to ensure training compliance, accurate documentation, and audit/inspection readiness.
- The ideal candidate will have hands-on experience in GxP/GMP environments, supporting training workflows, managing Learning Management System (LMS) assignments, maintaining training curricula, and developing training materials. Strong organizational skills, attention to detail, and cross-functional collaboration are critical to success in this role.
Key Responsibilities
- Administer training assignments, curricula, and compliance activities within the Learning Management System (e.g., SuccessFactors).
- Maintain accurate training records, monitor overdue training requirements, and support remediation efforts.
- Collaborate with QA Operations and functional leaders to support onboarding programs, On-the-Job Training (OJT) documentation, and role-based training curricula.
- Assist with the development, revision, and formatting of training materials, including instructor-led training (ILT) decks, SOP-based content, and job aids.
- Generate routine and ad-hoc training compliance reports for stakeholders and leadership.
- Support continuous improvement initiatives related to training processes, documentation quality, and user experience.
- Coordinate training sessions, logistics, communications, and stakeholder reminders to ensure timely completion of training activities.
Required Qualifications
- Bachelor’s degree in Science, Engineering, Biochemistry, or a related discipline.
- 3+ years of experience managing or coordinating training in a GMP/GxP-regulated environment, including training assignments, compliance tracking, and overdue training remediation.
- 2+ years of experience working with Learning Management Systems (LMS) such as SuccessFactors, ComplianceWire, or Cornerstone.
- 2+ years of experience developing and maintaining training materials, including SOP-based training, instructor-led training, on-the-job training, and e-learning modules.
- Strong project/task management skills with the ability to manage multiple training assignments and deadlines.
- Knowledge of U.S. and EU cGMP regulations and regulatory guidelines (FDA, EMA, or other regulatory authorities).
