Responsibilities:

• Reports directly to the Associate Director of CMC QA, supporting CMC/GMP
• Review master batch records, master labeling/packaging records, product specifications and other process related documents from contract sites
• Perform batch record and data review/approval
• Review and/or approve deviations, OOSs, CAPAs, change control in an efficient manner for adequate and timely closeout of these events (internal and third party as relevant)
• Review and approve manufacturing and analytical validation protocols and reports.
• Support CMC QA document review, as assigned
• Assist in complaint investigations
• Review and approve product stability protocol and reports
• Assist in GMP Vendor audit and audit action completion. Schedule, conduct and provide timely reports of audits to assure conformance with the approved audit schedule, and to confirm compliance with regulations, guidelines, SOPs, and Industry standards
• Assist with Internal QA Audits, as assigned, ensuring timely conduct, reporting, and follow-up
• Perform initial and/or technical review of draft quality agreements prior to signatory review
• Utilize eQMS for quality workflows and for effective tracking, trending, and reporting of quality data and information
• Write, revise, and periodically review SOPs to further develop the Quality System and control over compliance and the quality of data, vendor services, and products
• Manage quality issues and investigations, root cause analyses, risk assessments and risk impact analyses, as well as corrective and preventive actions (CAPAs)
• Clearly communicate quality, compliance, and audit issues to internal and external parties, professionally, and in a timely manner
• Support Regulatory Compliance and Inspection Activities
• Participate in Computer System Validation and Testing
• Draft Validation documentation (protocols, reports) for eQMS workflows
• Review and sign off on validation and testing documentation
• Support GMP Vendor Document archival
• Develop and deliver, staff training on topics related to Quality, GxP Compliance, SOPs, and Risk Management
• Perform other quality assurance advisory duties as assigned by the Associate Director of CMC QA

Job characteristics:

• Working independently in a geographically distributed team
• Being proactive, target driven and diligent
• Working with multiple stakeholders and managing multiple priorities
• Contributing to an overall culture of quality within the organization
• Skilled in negotiation and communicating internally and externally with personnel of all levels of seniority

Requirements:

• 5+ years experience working in GMP Quality Assurance/Management
• Bachelor’s degree in a scientific field
• Documented training and knowledge of current FDA Regulations and GxPs
• Experience reviewing GMP manufacturing batch documentation (preferably late phase-commercial)
• Experience reviewing GMP analytical documentation (testing, CoA, protocols, reports, test methods, etc.)
• Experience with electronic quality management system(s) is a plus (e.g Veeva, MasterControl, TrackWise, etc.)
• Experience working in a manufacturing or laboratory environment prior to QA is a plus
• Experience in conducting and reporting GXP vendor audits is a plus
• Experience with Process Validation is a plus
• Experience with NDA submission(s) is a plus
• Proficient written and verbal communication skills
• A can-do attitude and excellent attention to detail

The starting base pay range for this position is $105,556.00 - $139,388.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave and some fun fringe perks!