Quality Control, Raw Materials Specialist
Cellectis’ Quality organization is seeking a highly motivated Quality Control– Raw Materials Analyst to complete daily QC Raw Materials activities and documentation including but not limited to testing of biological starting materials, raw materials testing, and material inspections.
The QC Specialist, Raw Materials will be responsible for supporting method development, verification, qualification and GMP release testing for incoming raw materials at Cellectis’ GMP manufacturing facility in Raleigh NC. In a collaborative team environment, the incumbent will focus on a variety of analytical and bioanalytical methods used for raw material release testing. The QC Specialist will serve as the Subject Matter Expert (SME) for these methodologies, leading investigations for OOS and other non-conforming results. The specialist will author, review and/or approve policies, procedures, plans, protocols, and reports.
A potential candidate will possess expert knowledge of QC analytical techniques and a strong understanding of FDA/EMEA regulations. The QC Specialist may also support Management for activities related to interviewing of employees, compliance with GMP, and identifying and implementing corrective and preventive actions. This position will report to the QC Raw Materials Supervisor or Manager.
Responsibilities include but are not limited to the following:
• Develop, qualify and verify analytical methods, both compendial and non-compendial, used for incoming raw materials release testing,
• Perform routine and non-routine testing.
• Lead cross-functional investigations to determine root cause of OOS and other non-conforming results and implement appropriate corrective and preventative actions.
• Write, revise, review and train on SOPs, protocols and technical reports.
• Develop and lead training of QC personnel on analytical techniques.
• Serve as SME/Assay Leader during agency audits and inspections.
• Author Regulatory submissions and responses.
• Liaise with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs.
• Perform data review and approval to ensure adherence to standard operating procedures and cGMP.
• Other duties may be assigned.
Qualifications & Experience
• Bachelor's degree with 5+ years of relevant Ra relevant Raw Materials experience in a biopharmaceutical company orhands-on QC analytical laboratory experience.
• Flexibleand able totrain team members and others in a manner that promotes GMP compliant behaviors.
• Strong knowledge of USP/EP compendial methods.
• Ability to work independently, open to seeking guidance and a self-starter.
• Ability to manage multiple projects simultaneously.
• Strong understanding of Root Cause Analysis.
• Excellent oral and written communication skills.
• Strong understanding of cGMP compliance and aseptic manufacturing operations.
• Working knowledge of current global initiatives including Quality by Design, Process Validation and Data Integrity
• Knowledge of inspection and sampling plans as utilized in the biopharmaceutical industry (e.g. ANSI/ASQ Z1.4-2008, “Sampling Procedures and Tables for Inspection by Attributes” and √n+1.
• Experience with biological assays, such as ELISA
• Experience authoring Standard Operating Procedures and Work Instructions
• Hands on experience in sampling, inspecting, and raw material testing
• Working knowledge of regulations regarding cell/gene manufacturing and expectations of the Raw Materials Group including but not limited to cGMP as defined by the US Food and Drug Administration and European Medicines Agency.
• Strong written and verbal communication skills.
• Strong analytical and problem solving skills