GMP Training & Compliance Specialist (Remote)

Integrated DNA Technologies; Austin (TX); Remote; USD 70,000 - 90,000; Full time

Benefits offered by this job

Bonus eligibility

Benefits package including health/dent

Job summary

Integrated DNA Technologies (IDT), a Danaher operating company, seeks a Quality Systems Training Specialist to develop and maintain a GMP training program that aligns with global regulatory standards (21 CFR Parts 210/211/610, EU Annex 13, ICH Q7–Q10, ISO 9001/13485) and ensures training strategies and records meet quality requirements.

You will report to the Head, Document Control and Training in the Quality Assurance Team and work with cross-functional groups in a fully remote role, with about

Qualifications

• 3+ years creating and facilitating training programs in biotech, pharma, or medical device document control.
• Bachelor's Degree in life science or related field.
• Strong foundational knowledge in competency-based training and application-based training

Responsibilities

• Collaborate with cross-functional teams to establish and maintain training strategies aligned with regulatory requirements.
• Administer and maintain the LMS, including curricula, job codes, user access, qualification programs, and training records.
• Conduct impact assessments for new and revised procedures to determine training requirements and qualification activities.
• Monitor training compliance and address overdue or at-risk training with functional leadership.
• Provide guidance to managers and associates regarding training requirements and compliance obligations.

Skills

Training program development

Regulatory compliance

LMS administration

Education

Bachelor's Degree

Tools

MasterControl

Job description

Integrated DNA Technologies (IDT), a Danaher operating company, seeks a Quality Systems Training Specialist to develop and maintain a GMP training program that aligns with global regulatory standards (21 CFR Parts 210/211/610, EU Annex 13, ICH Q7–Q10, ISO 9001/13485) and ensures training strategies and records meet quality requirements.

You will report to the Head, Document Control and Training in the Quality Assurance Team and work with cross-functional groups in a fully remote role, with about