Quality Control Lead

The QC Lead External CTL Management is an individual contributor posting withing the Quality Control department. The QC Lead will oversee routine and non-routine testing and associated activities at Contract Testing Labs. This includes leading deviation and phase I investigation discussions and coordinating the review and approval of documents. The QC represents Intellia QC in partnership meetings, facilitates compliant documentation in support of GMP activities and triages deviation resolution by coordinating with Analytical Development, Quality Control and Quality Control. The lead will also interact with quality management systems by revising procedures, initiating, and completing deliverables for change controls.

Duties/Responsibilities

• Coordination of sample shipments to external CTLs.
• Coordination of routine testing activities and tracking associated deliverables.
• Communicating release testing forecast with vendor.
• Coordination of document exchange with CTLs and approving associated documents.
• Coordination of joint project mtgs with CTLs and serving as cross-functional team member.
• Monitoring of compliance issues during testing activities and coordinating with QC Management and Quality Assurance on the resolution of issues.
• Coordination of review and approvals of external documents and uploading into Veeva
• Coordination of review of external deviations and investigations, managing joint comment resolution, and coordinating approvals.
• Coordination of review and approval of external change controls and completing deliverables on associated internal change controls.
• Ownership of deviations within the quality management system.
• Data trending of assay performance.
• Support of regulatory filings.
• Support of GMP audits of contract testing sites.
• Support of GMP audits by contacted partners.
• Performs other related duties as assigned.

Requirements

Skills/Abilities

• Generates innovative solutions to problems, monitors results of assignments, identifies and understands issues, problems, and opportunities.
• Can gain buy in up, down and across the organization, can communicate clearly and accurately, can embrace change and shift gears comfortably.
• Works effectively and cooperatively with others, establishing and maintaining good working relationships.
• Knowledge of the use and interpretations of pharmacopeias such as USP/NF, EP, and JP.
• Knowledge and experience with electronic systems such as EDMS, LIMS, etc. preferred.
• Detail oriented and able to manage multiple competing priorities.
• Strong verbal and written communication skills. Technical writing including revising and reviewing SOPs, protocols, reports, technical assessments, and technical protocols and reports.
• Experience with and ability to effectively resolve technical issues using a variety of analytical methods such as HPLC, UV, CE, Bioassay, gel electrophoresis, MS, qPCR/ddPCR, MSD and compendial testing.
• Knowledge of method transfer, qualifications, and validations, including relevant guidelines (i.e. ICH, USP/NF, EP, JP, etc.).
• Proficiency with Microsoft Office Suite.
• Proficiency with Smartsheet.
• Proficiency with assay trending with JMP preferred
• Proficiency with Oracle preferred.

Education / Certifications

BS/BA or MS in relevant field.

Experience

• At least 5 yrs. GMP lab experience. Additional education in a relevant field can be substituted for equivalent years of experience

Physical Requirements

Prolonged periods of sitting at a desk and working on a computer.

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EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.