Quality Assurance Associate, Qualification Support (temporary)

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

Join Lumen as a QA Associate for Qualification Support in this temporary position. In this role, you'll support our Quality Assurance team in commissioning, qualification, and validation (CQV) activities that ensure compliance with pharmaceutical cGxP quality system processes. You'll contribute to equipment qualification workflows, maintenance management, and documentation that enable Lumen's commitment to quality excellence.
 
You'll perform tasks including document management, record review, preventative maintenance coordination, and SOP authoring. You'll work within 21 CFR part 210/211 standards, manage qualification documentation in our electronic quality management system (eQMS), and collaborate across manufacturing and quality control teams to maintain equipment readiness and regulatory compliance.

Duties and Responsibilities:

• Support QA Associate and QA Specialist in commissioning, qualification, and validation (CQV) related tasks.
• Perform scanning and archival of CQV documents and records.
• Review maintenance and calibration related records for accuracy and completeness.
• Work with manufacturing and quality control to ensure timely completion of preventative maintenance and calibration activities.
• Assist with writing or reviewing qualification and validation standard operating procedures (SOPs).
• Assist with writing or reviewing operation and maintenance procedures.
• Determining equipment qualification gaps for manufacturing and quality control.
• May assist in the preparation of CQV metrics reports.
• May assist with the investigation and triage of CQV related 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.
• 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.