Quality Assurance Associate
About The Position
The Quality Assurance Associate is an enthusiastic, self-motivated person with great communication skills. Along with the duties described below, this individual performs quality support to the internal quality framework including developing quality documentation and processes to support quality (e.g., audits, CAPAs, deviations, etc.). The Quality Assurance Associate must demonstrate a high level of individual responsibility and accountability and possess the ability to perform to the requirements listed below. The QA Associate must be comfortable in a rapidly evolving Biotech start-up environment. This is a part-time role with an expected schedule of approximately 28 hours per week. Specific workdays and hours will be determined based on business needs.
Requirements
- BS in a biological science or similar field of study preferred.
- Excellent organization skills allowing the coordination of multi-faceted QA activities.
- Strong attention to detail, organization, and teamwork skills.
- Ability to prioritize multiple tasks concurrently and meet deadlines.
- Excellent writing and digital literacy.
- Ability to proactively communicate in a consistent, clear and open manner.
- Flexible, adaptive and comfortable in a rapidly evolving Biotech start-up environment.
- 1-2 years of pertinent industry experience is preferred.
- Experience with deviations, lab investigations, Out of Specification and CAPAs preferred.
- Strong knowledge of Microsoft Office applications.
- Excellent written and verbal communication skills.
- Ability to proactively communicate in a consistent, clear, and honest manner.
- Flexible and adaptive in a frequently changing environment.
- Knowledge of QMS standards.
- Strong analytical and problem-solving skills.
- Excellent attention to detail and organizational skills.
Responsibilities
- Supports / administers document control system, including revision and maintenance of lab documents to ensure compliance with CLIA regulations.
- Ensures that all documents are current, properly stored, and accessible to relevant personnel.
- Assists with personnel onboarding (introduction to controlled document system, personnel binders) and tracking of training, competency, and continuing education status.
- Ensures that documentation of training and competency records are prepared for review.
- Maintains standard operating procedures (SOP), work instructions and quality records for quality assurance systems.
- Ensure that all documents are current, properly stored, and accessible to relevant personnel.
- Review and improve existing quality procedure workflows, and identify areas of improvement for efficiency and compliance.
- Administers training materials and modules for the GLP activities.
- Support internal and external (regulatory) audits as required.
- Helps maintain Karius Quality records in a state of inspection readiness.
- Support continuous improvement initiatives including existing quality procedure workflows, aspects of the quality management system, etc.
- Provides administrative support of incident management system.
- Supports documentation needs of Karius core teams (routing validation packages, laboratory change control forms).
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What This Job Offers
Job Type
Part-time
Career Level
Entry Level
Education Level
Associate degree
