Quality Assurance Associate I

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.

• 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.

• →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.

• 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.

• Ability to sit and stand for extended periods (2+ hours each).
• Occasionally lift or carry items up to 20 kg.