Quality Assurance Associate I

Quality Assurance Associate I at Lumen Bioscience Lumen Bioscience is seeking a dedicated Quality Assurance (QA) Associate I to assist with maintaining our quality management system. This essential role supports compliance activities related to cGMP, cGLP, and cGCP (cGXP) standards, ensuring high-quality documentation, thorough reviews, and operational adherence to pharmaceutical regulations. If you have a keen eye for detail, excellent organizational skills, and a commitment to quality, we encourage you to apply. Role Description: Documentation and Records: Perform document scanning and archival of controlled records, maintain accurate activity logs, and issue process documentation for manufacturing operations. Operational Support: Provide on-the-floor QA support to manufacturing operations, assisting in ensuring compliance with established cGXP processes. Batch Record Review: Conduct detailed reviews of batch records and related process documentation to uphold stringent quality standards. Compliance Walkthroughs: Regularly conduct facility and operational walkthroughs to verify compliance with the company's quality management system aligned with 21 CFR parts 210/211. QA Team Support: Assist the QA Manager and QA Specialist in various quality assurance tasks, including metric report preparation and quality event investigations. Essential Duties and Responsibilities: Maintain organized documentation through scanning, archiving, and record-keeping. Issue and review process documentation associated with manufacturing schedules. Support on-the-floor quality assurance for manufacturing compliance. Perform facility walkthroughs to ensure adherence to 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. Qualifications & Requirements: Educational Background: Associate's degree in a relevant scientific field, or at least 1 year of work experience in a regulated cGXP environment. Technical Knowledge: Familiarity with cGMP, ISO 9001, and ICH requirements related to document control and quality records. Technical Skills: High proficiency in Microsoft Word, Excel, and SharePoint. Personal Attributes: Strong organizational skills, detail-oriented, ability to multitask, excellent communication skills, adaptability, and commitment to quality and ethical standards. Physical Requirements: Ability to sit and stand for extended periods (2+ hours each). Occasionally lift or carry items up to 20 kg. Salary & Benefits at Lumen Bioscience: $65,000 - $70,000 annually Health, Dental, and Vision premiums fully covered by Lumen. 401k match up to 4%, in addition to annual stock bonuses for all employees. Industry-leading PTO policy, paid refresh days, and year-end holiday office closure. Monthly wellness programs to support employee health. Free onsite parking or public transportation subsidies. Comprehensive parental leave. Life insurance, short & long-term disability, and employee assistance programs. At Lumen Bioscience, we foster a collaborative and innovative work environment where your contributions directly impact biotechnology and global health solutions. Join us and play a vital role in maintaining exceptional quality standards and regulatory compliance. Compensation Range $65,000—$70,000 USD