QA Compliance Sr. Specialist/Manager, Supplier Quality Management
CRISPR seeks a Quality Assurance professional to support the company’s QA Compliance program. As part of the CRISPR Supplier Quality Management group, the successful candidate will perform a broad range of external and internal audits and take part in the development and improvement of existing Quality Systems to ensure the QMS operates in compliance with applicable regulations, guidelines, and management expectations. In addition, the candidate will participate in sustaining inspection readiness at CRISPR and support continuous QA improvement, among other administrative tasks.
- Compliance Audits (external) = 60%
- Perform supplier risk assessments to determine and evaluate audit frequency.
- Conduct audits alone or with contract auditors as appropriate.
- Ensure smooth execution of audits by arranging audit dates, preparing audit agendas, and scheduling kick-off/close out meetings with internal and external stakeholders.
- Conduct supplier qualification or for-cause audits of raw material suppliers including Contract Manufacturers and Contract Laboratories, either as Lead Auditor or as an audit team member.
- Perform evaluations of Supplier Quality systems and practices to identify potential problems such as non-conformance to applicable SOPs and Quality Standards (GMP, ICH, GLP, etc.). Coordinate resolutions and provide guidance on quality/compliance risk levels as appropriate.
- Author/review audit reports, ensuring they are clear and cover the most important information to support successful development of CAPA’s.
- Communicate audit findings, including compliance risks, to external and internal stakeholders.
- Recommend approval or disapproval of suppliers based on compliance assessment.
- Review and evaluate auditee audit responses against current industry standards and guidelines
- Track auditee’s CAPA commitments and effectiveness.
- Prepare audit performance metrics and trends to identify potential risks and CAPA effectiveness. Ensure all audit documentation is appropriately archived.
- Compliance Audits (internal) = 20%
- Act as Lead Auditor or as a member of an internal audit team for Gap Assessment Audits (including training file audits, process audits, etc.).
- Schedule audit activities with internal groups and draft audit agendas.
- Perform evaluations to ensure stakeholder system compliance with existing policies and procedures, and cGMP regulations, standards and guidelines.
- Prepare audit reports and communicate findings to internal stakeholders.
- Provide recommendations to department management regarding results of audit and compliance risk levels.
- Review and evaluate internal audit responses to ensure applicable compliance.
- Drive closure of corrective and preventative actions in a timely manner confirming appropriate documentation, implementation, compliance and continuing efficacy are maintained.
- Track audit responses and auditee’s CAPA to verify that applicable metrics are recorded, and trends are analyzed.
- Regulatory Inspection Support = 5%
- Prepare for and support regulatory audits, client audits, or mock inspections by acting as scribe, reviewing documents, preparing operational staff to answer question, etc.
- Maintain current knowledge of Health Agencies regulations and guidance documents.
- Help ensure key operational groups are maintaining an on-going state of inspection readiness.
- Compliance Department Support = 15%
- Negotiate Quality Agreements with Contract Manufacturers, Suppliers and Distributors.
- Maintain annual internal and external audit schedules, and audit internal files and databases to ensure all statuses and documentation is complete and up to date.
- Lead and/or support QA continuous improvement projects.
- Assist in and/or lead the development of new and revised Quality Compliance SOPs, Forms, or WIs, and provide Quality training thereof, as required.
- Assist with trending and reporting of external and internal audit metrics for inclusion in periodic Management Reviews.
- Positively impact the company by maintaining Quality through successful contributions, identification of compliance gaps, and being an advocate for Quality Compliance.
- BS in biology or related discipline, with 2-5+ years of relevant research experience
- Significant experience with RNA chemistry, structure and synthesis.
- Molecular biology techniques: DNA & RNA isolation and PCR (qRT, ddPCR, etc) and biochemical expertise
- Experience with flow cytometry, including preparation of samples and analysis
- Excellent oral and written communication skills
- Track record of intellectually challenging oneself to enhance scientific capabilities
- Ability to work independently as well as part of a results-oriented cross-functional research team; highly organized with significant attention to detail
- Prior experience with CRISPR/Cas9 and/or modulating gene expression using siRNA, shRNA, or gene-editing platforms
- Experience with assay development, NanoString, automation and NGS
- Protein expression, purification, and biophysical characterization
- Collaborative – One Team.
- Undaunted – Fearless. Can-do attitude.
- Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.
Crispr Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.