Quality Assurance - Document Specialist

Organization: Neurona Therapeutics

Position: Quality Assurance, Document Specialist

Location: San Francisco Bay Area

Manager: VP, Quality Control and Assurance

Status: Exempt

Position Summary:

Administers quality policies and procedures internally and across Neurona, serving as a liaison to ensure appropriate levels of GMP compliance. The Quality Assurance Document Specialist will execute quality assurance activities related to review and approval of GMP documents such as Standard Operating Procedures (SOPs), batch records, material review and release, investigations, Corrective And Preventive Actions (CAPA), protocols, procedures, qualification and validation reports. He/she will demonstrate a high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.

Position Responsibilities:

• Assign SOP numbers for tracking purposes, insure Neurona's format is followed, finalize and distribute new documents to Neurona users. Task includes maintaining logs of existing SOPs, informing users of biennial review and creating binders with current SOPs.
• Maintain training records for GMP personnel. Communicate of new documents and annual GMP training.
• Reviews records including Executed Batch Production Records, raw data supporting manufacturing and testing, instrument qualification documentation and Certificate of Analysis to verify accuracy and alignment with regulations. This task includes receiving, controlling, scanning and archiving completed Neurona manufacturing production records.
• Ensure that Neurona equipment is calibrated and qualified by coordinating calibrations and keeping the logbooks up to date.
• Support internal and external audits; including preparing agendas, coordinating audit dates, and following up on finding.
• Advocate and maintain quality systems and policies throughout the company.
• Assist in additional quality functions as needed.

Requirements:

• Bachelor's Degree in chemistry, pharmaceutical science or related field or equivalent; at least 2 years of pharmaceutical experience, including experience with quality systems.
• Minimum 2 years of Pharma/Biotech industry in a Quality environment.
• Excellent computer skills (Word, Excel, PDF, Visio and outlook) with knowledge of spreadsheet, word processing and database software.
• Excellent verbal and written communication skills, experience with scientific technical writing including authoring and revising SOPs or technical reports.
• Attention to detail as applied to data review; excellent analytical skills applied to investigations.
• Experience with key quality systems (e.g., Change Management, Vendor Management, Deviations/CAPA, and Management Review); experience with electronic systems is a plus.