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
- 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 email@example.com 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.