Quality Assurance Specialist - GLP Compliance
BTS Research, a leading Preclinical Contract Research Organization in San Diego, is seeking a highly motivated and experienced Quality Assurance Specialist to join our team. This role is responsible for ensuring quality assurance and compliance with Good Laboratory Practice (GLP) standards within our vivarium facility.
Key Responsibilities
Quality Systems Management (40%)
- Oversee the development, implementation, and maintenance of robust quality systems, with a primary focus on GLP compliance.
- Ensure all activities and processes comply with GLP standards, FDA, USDA, and AAALAC regulations.
- Conduct regular GLP audits and assessments to identify areas for improvement and ensure adherence to quality standards.
- Lead inspections and audits by regulatory agencies and external auditors, focusing on GLP compliance, and ensure timely resolution of findings.
- Monitor and maintain Standard Operating Procedures (SOPs), ensuring their effectiveness, relevance, and strict compliance with GLP and regulatory standards.
Compliance Oversight (20%)
- Monitor changes in GLP requirements and industry trends, implementing necessary changes to maintain compliance.
- Develop and maintain policies, procedures, and guidelines to ensure compliance with GLP standards, industry best practices, and OSHA regulations.
- Provide guidance and support to cross-functional teams on GLP compliance-related matters.
Equipment IQ/OQ and Validation (20%)
- Oversee the installation qualification (IQ) and operational qualification (OQ) processes for new equipment to ensure GLP standards are met.
- Develop and implement validation protocols for equipment and processes, ensuring comprehensive documentation and GLP adherence.
- Conduct periodic reviews and requalification of equipment to ensure ongoing compliance and performance consistency.
- Collaborate with vendors and internal teams to resolve issues identified during qualification and validation processes.
Training and Development (20%)
- Develop and deliver training programs on GLP compliance, quality systems, and regulatory requirements to ensure staff competency and awareness.
- Provide coaching and mentorship to the Quality Assurance and Compliance department, fostering professional growth and development in GLP principles.
Qualifications
- Bachelor's degree in a relevant scientific field or equivalent experience.
- Minimum of 2 years of experience in quality assurance or compliance with a strong focus on GLP within a vivarium or similar regulated environment.
- Strong understanding of GLP regulatory requirements and industry standards.
- Experience with equipment installation qualification (IQ) and operational qualification (OQ).
- Excellent communication and interpersonal skills.
- Ability to work effectively in a team environment and manage multiple priorities.
Preferred Qualifications
- Certification in quality assurance or regulatory affairs (e.g., Certified Quality Auditor, Regulatory Affairs Certification).
- Experience with vivarium operations and animal research regulations.
- Demonstrated experience in leading quality management systems, regulatory inspections, compliance programs, and SOP monitoring and maintenance.
Job Type: Full-time
Pay: $66,560.00 - $70,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Employee assistance program
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
- Professional development assistance
- Tuition reimbursement
- Vision insurance
Experience level:
Schedule:
Experience:
- Preclinical: 3 years (Required)
- GLP: 3 years (Required)
- Vivarium: 3 years (Required)
Ability to Commute:
- San Diego, CA 92121 (Preferred)
Ability to Relocate:
- San Diego, CA 92121: Relocate before starting work (Required)
Work Location: In person