The Quality Control (QC) Associate is responsible for tasks associated with maintaining a quality management system, including analyzing materials using various instrumental and analytical techniques; performing qualification, verification, and validation activities; and maintaining and reviewing cGxP records.

The major tasks for this position are as follows:

• Maintain and operate laboratory equipment in a safe and efficient manner
• Sample preparation and analysis according to USP and House methods utilizing capillary electrophoresis, biolayer interferometry and other bio pharmaceutical techniques
• Coordinate sample analysis with third party labs
• Maintain accurate records of activities
• Review process documentation and contribute to continuous improvements in safety, quality, and efficiency
• Assist with preparation and execution of internal and 3rd party audits and other reviews

Education and Experience Required:

• Minimum 2 years of work experience in Quality Control in a regulated (cGXP) organization and/or an Associate or Bachelor’s degree in microbiology or related scientific field

The successful candidate will have the following attributes:

• Knowledge of relevant cGMP, ISO 9001, and ICH requirements for document control and quality records
• 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 level of proficiency in Microsoft Word, Excel, and SharePoint.
• High integrity and ethics

• Commitment to quality and timely delivery of results

Physical Requirements

• Sit for extended periods of time (2 or more hours)
• Standing for extended periods of time (2 or more hours)
• Occasionally lift or carry up to 20 kg

Please submit a resume and cover letter to jobs@lumen.bio with the job title in the subject line.

This position is available immediately. Applications will be reviewed upon receipt. Only successful applicants will be contacted.