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.

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 participate in 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
• Other duties as assigned

Skills required

• 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

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 $114,000. 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.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.