Senior Quality Control Analyst

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.

Salary : $114,000