Careers

Regulatory Affairs/Quality Control Specialist

Job Description 

 

The Regulatory Affairs/Quality Control (RA/QC) Specialist 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.

Essential Duties and Responsibilities

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

Desired Qualifications and Requirements 

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

Application Instructions

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.