Laboratory Regulatory Affairs Specialist
2 months ago
Department: WI ACL Laboratories - Regulatory and Compliance
Status: Full time
Benefits Eligible: Yes
Hours Per Week: 40
Schedule Details/Additional Information: This is a full-time salaried position with standard work hours from Monday to Friday and occasional weekend travel.
Key Responsibilities:
- Conduct comprehensive internal risk evaluations of designated laboratories.
- Offer expert guidance and education during internal audits.
- Assist in coordinating both on-site and off-site evaluations.
- Manage the CAP website for relevant facilities.
- Maintain a high level of expertise in regulatory and accreditation requirements.
- Deliver training and educational sessions on compliance topics.
- Prepare detailed reports and presentations.
- Support enterprise-wide laboratory quality initiatives.
Minimum Education and Experience Required:
MT/MLS Certification or equivalent is mandatory.
A Bachelor's Degree in chemical, physical, biological sciences, or Medical Technology is required.
A minimum of 3 years of laboratory training and experience in a non-waived laboratory setting.
At least 2 years of supervisory experience in a diagnostic laboratory environment.
Knowledge, Skills, and Abilities Required:
- Ability to work autonomously as well as collaboratively.
- Strong leadership, teaching, and coaching capabilities.
- Excellent organizational and planning skills.
- Sound decision-making abilities.
- Highly motivated with a results-oriented mindset.
Physical Requirements and Working Conditions:
Travel is necessary, and exposure to various weather conditions is expected.
Must operate essential equipment for the role.
Work is conducted in a standard office environment.
A current state driver's license is required.
Must be capable of traveling, sitting, standing, and walking throughout laboratory settings.
This job description outlines the general nature of the work expected. It is not an exhaustive list of all duties and responsibilities.
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