What are the responsibilities and job description for the GLP Quality Assurance Lead position at Biomere (Biomedical Research Models, Inc.)?
Job Summary:
The QA Lead is responsible for supporting compliance with quality system procedures and all applicable Federal, State, Local, International, and Industry regulations in addition to company training, policies, guidelines, and standard operating procedures.
Responsibilities:
- Responsible for providing quality oversight and compliance verification for GLP requirements across GLP studies.
- Responsible for supporting Quality Management System processes and procedures including Document Control, Internal Auditing, Quality Management Review, and CAPA plans.
- Participate in the preparation and review of study and applicable QA files in preparation for sponsor site visits and regulatory inspections; assure that QA audit files are retained.
- Participate as GLP QA expert on GLP studies at facility audits.
- Co-host/represent the company at regulatory inspections, client inspections and study monitoring events.
- Provide support to Quality and Compliance by writing, editing, or reviewing responses and submissions of pre-audit questionnaires, audit response documents, and corrective action implementation and/or response.
- May be responsible for coordinating, authoring, and revising controlled documents including, but not limited to; company policies, guidelines, and SOPs.
- Participate in ad-hoc tasks and projects in the QAC department
- Collaborate with senior staff to implement inspection and audit readiness activities.
- Partner with scientists and the Quality Team to support the review of study data and review study reports for compliance against standard operating procedures, protocols, and GLP/GCLP regulations (as applicable).
- Interact professionally with company management, senior staff, and third parties as required to provide effective compliance management and guidance.
- May be responsible to Identify the required initial and continuing training for quality systems and compliance and ensures all employees are trained on appropriate curricula.
- Complies with all regulatory guidelines, occupational health as well as health and safety programs, in accordance with company policies and procedures.
- Performs all other duties as required.
Education and Experience Requirements:
Required: Associate’s or Bachelor’s degree in Science (or equivalent) preferred.
- Certifications preferred: ASQ, GLP
- 5 years of experience within preclinical GLP Quality Assurance
Skill Requirements:
Functions independently with guidance from the head of QD and the head of QAC.
- Improves company quality assurance and compliance program in collaboration with senior staff.
- Edits and/or creates company policies, guidelines, and SOPs in collaboration with senior staff.
- Edits and/or creates training on QA, Quality Systems, and regulatory policies in collaboration with senior staff.
