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Lumos Pharma · 1 month ago

Clinical Quality Assurance Specialist

United States

Full-time

Remote

Entry, Mid Level

1+ years exp

Lumos Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for rare diseases. The Clinical Quality Assurance Specialist is responsible for overseeing clinical trial activities, ensuring compliance with Good Clinical Practices, and supporting internal quality systems and compliance functions.

BiopharmaBiotechnologyClinical TrialsHealth CarePharmaceutical

Responsibilities

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

Qualification

GCP knowledgeQuality assurance experienceGMP knowledgeMicrosoft OfficeMasterControl experienceCDER BIMO inspectionsAnalytical skillsBusiness acumenCommunication skillsRelationship buildingDecision-making skills

Required

Bachelor's Degree (four-year college or technical school) required, Field of Study: Biology, Chemistry, Health Administration, or related technical discipline

1-3 years of experience in quality assurance within the pharmaceutical or biotech industry

Preferred

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

Benefits

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