Careers

Regulatory Affairs/Quality Assurance Associate

Job Description 

The Regulatory Affairs/Quality Assurance (RA/QA) Associate is responsible for assisting with tasks associated with maintaining a quality management system, including conducting cGLP/cGMP/cGCP (cGXP) facility walkthroughs, auditing documentation compliance, assisting in submission of regulatory packages and documentation, and maintaining production records as well as all regulatory affairs functions.

Essential Duties and Responsibilities 

The major tasks for this position are as follows:

  • Conduct facility and operations walkthroughs, observations, and process audits to ensure compliance with the Company’s 21 CFR part 210 /211 standard pharmaceutical cGXP quality system processes
  • 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
  • Assist with GXP Validation, Qualification and Verification activities

Desired Qualifications and Requirements 

Education and Experience Required:

  • Minimum 1 years of work experience in Quality Assurance, Quality Control, or Regulatory Affairs in a regulated (cGXP) organization or a minimum of an Associate’s degree in a relevant 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.