QA Associate, OTF Support (temporary)

Six-month position. 

Join Lumen as a QA Associate for OTF Support in this temporary position (schedule below). 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 & Responsibilities:

This position requires working under the 21 CFR part 210 /211 standard pharmaceutical cGXP quality system processes.

• 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:

• Education and Experience:
  • Minimum 1 year of work experience in a regulated (cGXP) organization or a minimum of an associate's degree in a relevant scientific field
  • Knowledge of relevant cGMP, ISO 9001, and ICH requirements for document control and quality records
  • High level of proficiency in Microsoft Word, Excel, and SharePoint.
• Skills and Attributes:
  • Well-organized and detail-oriented with strong technical skills, excellent written and verbal communication skills, and proven ability to multitask
  • Strong interpersonal skills and the ability to effectively collaborate with others in a dynamic team environment
  • Capable of supporting multiple projects simultaneously in a deadline-driven environment
  • Adaptability, flexibility, independence, and resourcefulness to thrive in a fast-paced, small-company environment
  • High integrity and ethics
  • Commitment to quality and timely delivery of results

Physical Requirements:

• Schedule: 10:00 AM-6:00 PM, Monday-Friday 
• Ability to sit/stand for extended periods of time (2 or more hours)
• Occasionally lift or carry up to 23 kg

Benefits at Lumen Bioscience:

• Free onsite parking

At Lumen Bioscience, we foster a workplace built on collaboration, innovation, and professional growth. This role offers a significant opportunity to contribute directly to cutting-edge biotechnology and the advancement of global health solutions.

Join us to shape innovative solutions and drive operational excellence.