Quality Assurance Associate I
About The Position
Lumen Bioscience is seeking a Quality Assurance Associate I to help maintain its quality management system and support compliance with cGMP, cGLP, and cGCP (cGXP) standards. The role focuses on accurate documentation, thorough batch-record and process-documentation reviews, and adherence to pharmaceutical regulations. The associate supports manufacturing operations on the floor, conducts facility and operational walkthroughs to check compliance with the quality management system and 21 CFR Parts 210/211, and assists with documentation control, quality-event investigations, audits, and validation, qualification, and verification activities. The position also supports the QA Manager and QA Specialist with quality assurance tasks and metric reporting.
Requirements
- Associate's degree in a relevant scientific field, or at least 1 year of work experience in a regulated cGXP environment.
- Familiarity with cGMP, ISO 9001, and ICH requirements related to document control and quality records.
- High proficiency in Microsoft Word, Excel, and SharePoint.
- Strong organizational skills, attention to detail, and ability to multitask.
- Excellent communication skills and adaptability.
- Commitment to quality and ethical standards.
- Ability to sit and stand for extended periods of 2 or more hours.
- Ability to occasionally lift or carry items weighing up to 20 kg.
Responsibilities
- Scan, archive, and maintain organized controlled records and accurate activity logs.
- Issue and review process documentation associated with manufacturing schedules and operations.
- Provide on-the-floor quality assurance support to manufacturing operations and help ensure compliance with established cGXP processes.
- Review batch records and related process documentation.
- Conduct facility and operational walkthroughs to verify compliance with the quality management system and pharmaceutical regulatory requirements.
- Assist with investigations and management of deviations, CAPAs, and other quality-related events.
- Support internal and external audits, validation, qualification, and verification activities as needed.
- Assist the QA Manager and QA Specialist with quality assurance tasks, including preparing metric reports.
Benefits
- Health, dental, and vision premiums fully covered by Lumen.
- 401(k) match up to 4%.
- Annual stock bonuses for all employees.
- Industry-leading PTO policy.
- Paid refresh days.
- Year-end holiday office closure.
- Monthly wellness programs.
- Free onsite parking or public transportation subsidies.
- Comprehensive parental leave.
- Life insurance.
- Short- and long-term disability coverage.
- Employee assistance programs.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
