Quality and Compliance Specialist

Lumos Pharma; United States; Remote; USD 60,000 - 90,000; Full time

Job summary

Lumos Pharma is seeking a Quality and Compliance Specialist to support product development and clinical trial activities. The role involves ensuring compliance with quality assurance processes, reviewing documentation, and collaborating with internal and external stakeholders. Ideal candidates will have a Bachelor's degree in a relevant field and experience in the pharmaceutical or biotech industry. Join us in making a difference in the treatment of rare diseases.

Benefits

Generous health and welfare benefits

Company-paid dental and vision benefits

Short-term and long-term disability

8 weeks of fully paid parental leave

Qualifications

• 1-3 years of experience in quality assurance within the pharmaceutical or biotech industry.
• Knowledge of GMP and GCP regulations preferred.
• Strong attention to detail and organizational skills.

Responsibilities

• Perform batch record review and analytical data review.
• Review and approve SOPs and other applicable documents.
• Assist with audits of clinical trial sites.

Skills

Analytical Skills

Communication

Relationship Builder

Business Acumen

Decision-Making/Judgment

Education

Bachelor’s Degree in Biology, Chemistry, or related technical discipline

Tools

Microsoft Office

MasterControl

Job description

Transforming Lives with Breakthrough Therapies!

At Lumos Pharma, we are on a mission to revolutionize the treatment of rare diseases. As a cutting-edge clinical-stage biopharmaceutical company, we are focused on developing innovative therapies where the need is greatest and the science is clear. Our unwavering commitment is to bring safe, effective, and innovative treatments to patients through a strategy that values time and cost efficiency.

Join us in our pursuit to make a difference. Together, we can change the future of medicine!

This position reports to the Vice President, Quality and Compliance and is responsible for providing quality support of product development and clinical trial activities and associated functions performed by external contract research, development and manufacturing organizations. This position also supports internal quality systems and compliance functions. The Quality and Compliance Specialist is expected to execute established processes involving quality assurance, quality systems and compliance.

Key Responsibilities

• Perform batch record review, analytical data review and batch disposition process for investigational medicinal products
• Review and approve SOPs, master batch records, change controls, specifications and other applicable documents involving GMP production and supporting functions
• Provide input on deviation reports and associated corrective/preventive actions involving production, clinical trials and associated support functions
• Review and approve validation/qualification and stability protocols and reports involving investigational medicinal products
• 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 contract organizations
• Assist with audits of clinical trial sites and clinical studies (e.g., trial master file, clinical study report, etc.)
• Review and approve SOPs and other applicable clinical documents in accordance with GCP requirements
• Review and approve SOPs and other applicable compliance documents in accordance with OIG/DOJ expectations for clinical phase biopharmaceutical companies
• Assist with tasks involving the Compliance Review Committee
• 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 purchase decisions and completing compliance training in the time frames specified.

REQUIRED Qualifications

• Bachelor’s Degree ( four year college or technical school) Required, Field of Study: Biology, Chemistry, or related technical discipline
• 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

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

• 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 medical premium
• Health Reimbursement Arrangement
• 8 weeks of fully paid parental leave for all new parents