Quality Control Analyst-Senior
GENERAL SUMMARY (FUNDAMENTAL PURPOSE OF THE POSITION)
The Quality Control Senior Analyst performs product release and stability testing using capillary electrophoresis methods (CE-SDS, icIEF) and UV spectrophotometry, reports test results, and performs activities to support equipment qualification and preventative maintenance. General laboratory maintenance as assigned by management.
ESSENTIAL JOB FUNCTIONS* (PRIMARY RESPONSIBILITIES)
• Executes biochemical and chemistry release and stability testing using CE-SDS and icIEF following SOPs and records data in a GMP compliant manner.
• Supports release and stability testing using routine analytical techniques (e.g., concentration analysis by A280) as needed based on laboratory demand.
• Participates in validation and technical transfer of analytical methods commensurate with experience.
• Performs timely and accurate peer review of analytical test results reports.
• Performs preventative maintenance and/or calibration activities or coordinates and schedules these activities with a third-party provider. Responsible for cleanliness and orderliness of work area; maintains the laboratory in a state of inspection readiness; performs laboratory maintenance duties as assigned.
• Participates in QC continuous improvement initiatives; looks for ways to improve compliance or efficiency and communicates to management.
• Participates in laboratory investigations and root cause assessment and performs CAPA activities as assigned.
• Maintains required training and training records and provides training to qualify other Laboratory Associates.
CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES)
• Excellent oral and written communication, organizational, and interpersonal skills with ability to multitask while working under restrictive timelines.
• Ability to work in a team environment and perform job responsibilities with minimal supervision.
• Knowledge with analytical methods currently used for purity, potency identity and impurities testing for release and stability of biopharmaceutical products.
• Fluency in Windows and Microsoft Office.
EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL)
• Associate’s Degree and a minimum of 5 years’ experience in chemistry, biology, pharmaceutical science or a Bachelor’s Degree and a minimum of 3 years of applicable GMP laboratory experience is required.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
your application has been submitted
Back to job search