Remote GMP Training Specialist — Life Sciences

Radiometer; United States; Remote; USD 70,000 - 90,000; Full time

Benefits offered by this job

Remote work arrangement

Bonus/incentive pay

Comprehensive benefits: medical/dental

401(k)

Job summary

Integrated DNA Technologies (IDT), a Danaher operating company, seeks a Quality Systems Training Specialist to design and maintain a GMP training program, collaborating with cross-functional teams to meet global regulatory standards.

This fully remote role administers the LMS, develops training strategies, qualifications, exams, and competency assessments, and monitors training compliance. Travel up to 10% to Fargo, ND and Coralville, IA may be required.

Qualifications

• 3+ years of experience creating/facilitating training programs in biotech, pharma, or medical devices.
• Bachelor’s Degree required; life science related field preferred.
• MasterControl experience preferred.

Responsibilities

• Collaborate with cross-functional teams to establish and maintain training strategies aligned with regulatory requirements.
• Ensure compliance with training requirements defined in applicable regulations and standards (21 CFR parts, EU guidelines, ICH/Q, ISO).
• Administer and maintain the LMS, including training assignments, curricula, job codes, user access, qualification programs, and training records.
• Conduct impact assessments for new and revised procedures to determine training needs and methods (Read & Understand, exams, instructor-led, competency assessments).
• Monitor training compliance, identify overdue training, investigate issues, and drive timely resolution with leadership.
• Provide guidance to managers and associates on training requirements, qualification expectations, and compliance obligations.

Education

Bachelor’s Degree in life science

Tools

MasterControl

Job description

Integrated DNA Technologies (IDT), a Danaher operating company, seeks a Quality Systems Training Specialist to design and maintain a GMP training program, collaborating with cross-functional teams to meet global regulatory standards.

This fully remote role administers the LMS, develops training strategies, qualifications, exams, and competency assessments, and monitors training compliance. Travel up to 10% to Fargo, ND and Coralville, IA may be required.