Lead QC Analyst, QC Operations

Job Summary

Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Proactively identifies gaps, takes ownership of problems beyond the immediate scope of assigned tasks, and drives initiatives to completion with minimal direction. Demonstrates the confidence and sound judgment to make decisions independently and to lead cross-functional efforts when required.

Responsibilities

• Provide timely analyses to support manufacturing and stability, assuring that deadlines are met, maintaining data integrity and ensuring compliance with company SOPs and specifications
• Independently operate, maintain and troubleshoot laboratory instrumentation and equipment in a safe working Identify and implement appropriate instrumentation or techniques. Provide training to junior analysts on instrumentation, techniques, and test methods
• Revise and create standard operating procedures (SOPs), author and review technical Implement QC protocols and SOPs with training provided to junior analysts for execution.
• Conduct lab investigations and independently lead the development and implementation of corrective actions and improvements
• Function as QC SME for select test methods and equipment to support method validations, serve as point of contact for service providers during routine PM/CAL and repair of equipment
• Uphold QC compliance by supporting QC document revisions, data review, laboratory housekeeping, equipment PM/CAL review, equipment and supplier assessments, as needed
• Take initiative to identify process gaps, propose solutions, and drive improvements proactively - without waiting to be directed - escalating risks and decisions appropriately while maintaining accountability for outcomes
• Other duties as assigned

Skills required

• Demonstrated ability to work independently and exercise sound judgment; self-directed, takes initiative, and is comfortable owning decisions and outcomes without close supervision
• Well-organized, capable of multi-tasking, strong interpersonal skills in order to collaborate with individuals in a matrix environment
• Expertise in performing relevant analytical techniques (HPLC, GC, FTIR).
• Extensive experience with EMPOWER with excellent data analysis skills and attention to detail and interpretation of results
• Excellent written, oral communication skills, and experience with computer software such as WORD, EXCEL,
• Excellent knowledge of method validation, transfer requirements, and laboratory investigations
• Proven track record of leading projects or initiatives, with the confidence to set priorities, rally stakeholders, and see work through from conception to completion

Education and experience

• Bachelor's Degree in science or related field
• 8+ years relevant experience in a cGMP pharmaceutical QC environment or 5+ years with a Master's degree

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Potentially prolonged periods standing
• Must be able to lift up to 15 pounds at times
• Must be willing to travel

Compensation

The base salary for this role starts at $121,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes diverse health and other benefits and an annual target bonus for full-time positions.