Quality Assurance Associate, OTF Support (contractor)

Quality Assurance Associate at Lumen Bioscience — three to six month contract position. 

Join Lumen as a QA Associate for OTF Support on an independent contractor basis. In this role, you’ll help maintain our cGxP-compliant quality management system by supporting cGLP/cGMP/cGCP activities, conducting facility walkthroughs, and ensuring production records and documentation are complete, accurate, and audit-ready. Your work will directly support Lumen’s commitment to operational excellence and regulatory compliance across our manufacturing operations.

You’ll perform tasks including controlled document scanning and archival, batch record and process documentation review, issuance of process documentation for scheduled manufacturing runs, and on-the-floor QA support for production teams. You’ll help monitor compliance with 21 CFR part 210/211 standards through routine facility and operations walkthroughs, maintain high-quality records of activities, and collaborate closely with QA leadership to support investigations, metrics reporting, and continuous improvement of our quality systems.

Duties and Responsibilities:

• Perform document scanning and archival of controlled records.
• Maintain accurate records of activities.
• Perform on-the-floor support for manufacturing operations.
• Perform issuance of process documentation for scheduled manufacturing operations.
• Perform review of Batch records and related process documentation.
• Conduct facility and operations walkthroughs to ensure compliance with the Company’s 21 CFR part 210 /211 standard pharmaceutical cGxP quality processes.
• Support the QA Manager and QA Specialist in all QA related tasks.
• May assist in the preparation of metrics reports.
• May assist with the investigation and triage of deviations, CAPAs, or other quality events.

Qualifications & Requirements:

• Educational Background: Bachelor's degree in a relevant scientific field, and/or experience in a cGXP or other regulated environment.
• Technical Knowledge: Knowledge of relevant cGMP, ISO 9001, and ICH requirements as it relates to equipment and qualification. 
• Technical Skills: High proficiency in Microsoft Word, Excel, and SharePoint. Capable of supporting multiple projects simultaneously.
• Personal Attributes: Well-organized, detail-oriented, strong technical skills, excellent written and verbal communication skills. Strong interpersonal skills and the ability to effectively collaborate with others in a dynamic team environment.

Physical Requirements:

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

Benefits at Lumen Bioscience:

• Free onsite parking or public transportation subsidies.

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.