Are you a Senior Scientist passionate about supporting high quality preclinical and clinical drug candidates through excellent GLP and GCP expertise? This could be the great next step you're looking for!
What You'll Do: This position is within the Quality Assurance department and supports ongoing development programs for both preclinical and clinical drug candidates. A key function of the role involves the continued development and maintenance of quality systems supporting Good Laboratory Practices (GLP) and Good Clinical Practices (GCP). You'll have an opportunity to work with numerous internal departments, as well as help support quality oversight functions for external partners.
Key Responsibilities Include:
Contribute to the development of a GLP quality and compliance systems to support non-clinical and clinical phase drug development
Writing, review, change control, approval, issuance, and organization of Standard Operating Procedures (SOPs)
Organization and control of quality, compliance, and project related documentation
Support utilization of an electronic document management system (Veeva QualityDocs)
Review and approval of internal and vendor generated documentation
Perform Quality related tasks in coordination with Bioanalytical and DMPK
Issuance, review, tracking, and completion of internal deviations, out of specifications, and CAPAs
Auditing of vendor and internal documentation and files
Assisting with generation, tracking, monitoring, and reporting of key quality metrics
Maintain knowledge of current compliance expectations and regulations pertaining to GLP/GCP testing
Collaborate with, and provide quality support for, other departments (Bioanalytical, DMPK, Project Management, Toxicology, Clinical Operations, etc.)
Participate in meetings with vendors and external organizations as the QA team representative
What You'll Bring:
Bachelor’s degree in a science field
Minimum of 8 years of experience in a pharmaceutical development company and/or contract research organization (CRO)
Working knowledge of drug GLP regulations, as well as ICH/FDA guidance documents
Previous experience with GLP/GCP quality systems, specifically 21 CFR Part 58
Prior experience with use of an electronic document management system in a regulated environment
Understanding of document control requirements in a FDA regulated organization
Competent knowledge of and ability to use Microsoft Word and Excel
Ability for occasional business travel
Excellent written and verbal communication skills and ability to communicate with internal and external parties
Ability to work with diverse professionals and promote cooperation, shared understanding, and commitment to ensuring best in class quality assurance protocols
Highly motivated team player willing to contribute to a growing pharmaceutical organization
Ability to work independently with minimal supervision and as well as manage priorities within a fast-paced environment
A detail-oriented self-starter who endeavors to anticipate and resolve problems and seeks opportunities to grow their role and responsibilities
Apply Now and move your career forward with a great team and rapidly growing leader! Questions? Contact Andie Veach directly at Andie@CarexScientific.com
Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.
