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.