Quality Systems Training Specialist

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

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Integrated DNA Technologies (IDT), one of Danaher's 15+ operating companies, our work saves lives and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. Our team at Integrated DNA Technologies (IDT), is united by a commitment to collaboration and scientific excellence, building on a strong foundation of innovation, expertise, and reliability. Guided by our vision to help researchers rapidly move from the lab to life-changing advances, we work closely with global partners to accelerate progress and genomics breakthroughs across fields like cancer, infectious disease, rare genetic disorders, and more. At IDT, you'll be part of a culture rooted in continuous learning and improvement- where your growth fuels our mission to accelerate the pace of genomics and helps shape a healthier, brighter future for all. Learn about the Danaher Business System which makes everything possible.

The Quality Systems Training Specialist is responsible for developing and maintaining a compliant GMP training program by partnering with cross-functional teams to ensure training strategies, qualification requirements, and learning activities meet global regulatory and quality standards.

This position reports to the Head, Document Control and Training and is part of the Quality Assurance Team and will be fully remote.

In This Role, You Will Have The Opportunity To

• Collaborate with cross-functional teams (internal and external) to establish and maintain training strategies that align with applicable regulatory requirements. Ensure compliance with training requirements defined in 21 CFR Part 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, ICH Q8, ICH Q9, ICH Q10, ISO 9001, ISO 13485 and other international guidelines as appropriate.
• Independently administer and maintain the electronic Learning Management System (LMS), including training assignments, curricula, job codes, user access, qualification programs, periodic reviews, and training record management.
• Conduct impact assessments for new and revised procedures to determine appropriate training requirements, delivery methods, and qualification activities, including Read & Understand, exams, instructor-led training, and competency assessments.
• Monitor training compliance, identify overdue or at-risk training activities, investigate training-related issues, and work directly with functional leadership to drive timely resolution.
• Provide guidance to managers and associates regarding training requirements, qualification expectations, and compliance obligations.

The Essential Requirements Of The Job Include

• 3+ years of relevant experience in creating/facilitating training programs; biotech, pharma, or medical device document control experience preferred. Experience with establishing and maintaining training programs in electronic document management systems, MasterControl experience preferred.
• Bachelor's Degree required; life science related field, preferred.
• Strong foundational knowledge in competency based/application based training.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• 10% travel to Fargo, ND and/or Coralville, IA required.

IDT, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

At IDT we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for IDT can provide.

The annual salary range OR the hourly range for this role is $70,000 - $90,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

For more information, visit www.danaher.com.

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The U.S. EEO posters are available here.

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We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].