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Clinical Quality Assurance Specialist
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Clinical Quality Assurance Specialist
Lumos Pharma is a clinical-stage biopharmaceutical company whose mission is to develop new therapies for people with rare diseases, prioritizing its focus where the medical need is high, and the pathophysiology is clear. We are committed to this mission and a strategy grounded upon time and cost-efficient drug development to deliver safe and effective therapies to patients. We take a patient-centric approach and maintain inspection-readiness across our programs.
This position reports to the Vice President, Quality and Compliance, and is responsible for providing quality oversight of clinical trial activities performed in compliance with Good Clinical Practices (GCP). This position also supports internal quality systems and compliance functions. The Clinical Quality Assurance Specialist is expected to execute established processes involving quality assurance, quality systems, and compliance.
ESSENTIAL FUNCTIONS
- Author, review, and/or approve SOPs, protocols, study plans, and other applicable clinical documents in accordance with GCP requirements
- Provide input on protocol deviations and associated corrective/preventive actions involving clinical trials.
- Perform audits of clinical trial sites and clinical studies (e.g., trial master file, clinical study report, etc.)
- Complete required tasks in the electronic quality management system
- Assist with training coordination, ensuring employees are up to date on quality and compliance requirements
- Assist with audits of external suppliers
- Routinely work with internal and external stakeholders to achieve cross-functional goals.
- Each employee is responsible for financial and compliance controls as they relate to their roles. For example, being fiscally responsible in purchasing decisions and completing compliance training within the specified time frames.
REQUIRED QUALIFICATIONS
Education
- Bachelor's Degree (four-year college or technical school) required, Field of Study: Biology, Chemistry, Health Administration, or related technical discipline
EXPERIENCE
- 1-3 years of experience in quality assurance within the pharmaceutical or biotech industry
PREFERRED QUALIFICATIONS
- Knowledge of GMP and GCP regulations
- Strong attention to detail, documentation accuracy, and organizational skills
- Microsoft Office
- Experience with MasterControl is desirable
- Experience with CDER BIMO inspections is desirable
COMPETENCIES
- Analytical Skills: Strong analytical skills with a strategic mindset for clinical development and commercialization.
- Communication: Excellent communication skills, with the ability to clearly articulate complex scientific information to technical and non-technical audiences.
- Relationship Builder: Ability to work effectively in a cross-functional team environment and to build relationships with internal and external stakeholders.
- Business Acumen: Business acumen is the ability to understand and discriminate between various business-related topics and issues.
- Decision-Making/Judgment: Decision-making skills look at the ability of the individual to select an effective course of action while controlling resources and expenditures.
WORK ENVIRONMENT
This position can work remotely in the United States.
TRAVEL EXPECTATION
Up to 10%
What you can expect as a Lumosian
- Industry-competitive compensation
- Generous health and welfare benefits, including company-paid dental and vision benefits with dependents coverage, short-term and long-term disability, and basic life Insurance.
- Lumos covers 85 – 95% of the medical premium
- Health Reimbursement Arrangement
- 8 weeks of fully paid parental leave for all new parents
- Gym or fitness class reimbursement
- 401(k) with 5% employer contribution
- Flexible work hours and location
- Generous PTO policy
- 11 paid holidays in the US
- Offices in Austin, TX, and Ames, IA
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