Offer summary

Qualifications:

Bachelor's Degree in Biology, Chemistry, or related technical discipline., 1-3 years of experience in quality assurance within the pharmaceutical or biotech industry., Knowledge of GMP and GCP regulations is preferred., Strong attention to detail and organizational skills. .

Key responsibilities:

Perform batch record review and analytical data review for investigational medicinal products.

Review and approve SOPs, master batch records, and change controls related to GMP production.

Assist with audits of external contract organizations and clinical trial sites.

Coordinate training to ensure compliance with quality requirements.

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

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 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

Required profile