KNOWLEDGE, SKILLS, ABILITIES

• Highly qualified in flow cytometric method transfer, method validation protocol drafting, and performing flow cytometry-based methods following cGMP practices and aseptic technique
• Demonstrable understanding of applicable regulatory requirements (ISO, ICH, FDA, EMA and USP) as it relates to analytical method transfer, phase-appropriate analytical method qualification and validation, safety testing and drug product stability
• Experience with NC/CAPA system, Change Control, New Product Introduction, Customer requests and complaint management preferred
• Technical writing experience specifically with regard to analytical method qualification/validation protocols, test method and test record design, and analytical reports is required
• Able to work independently and as part of a team with limited supervision
• Ability to build, use, and interpret scientific tables, charts, and graphs.
• Participate and provide input on timelines, potential compliance issues and other related QC activities.
• Able to read, comprehend, and make appropriate alterations to documents such as batch records, quality agreements, SOPs, etc.
• Sound interpersonal skills and a keen ability to multi-task in a detailed environment
• Proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., Quality Management System (QMS) software), including software programs generating reports and statistics.
• Work with diverse groups, guide teams through decision making, facilitate agreement, build collaborative relationships, and focus on customer needs.
• Apply experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
• Highly skilled in applying Quality tools e.g. FMEA, Risk Analysis, Root Cause Analysis
• Communicate articulately with colleagues within manufacturing, engineering, AD/PD and QC staff, to resolve technical issues and direct activities
• Detail oriented with the ability to clearly communicate in verbal and written form
• Proficient in MS Office (Word, Excel, Power Point, etc.) with a focus on protocol generation, data analysis and presentations
  At Thermo Fisher Scientific, each one of our 65,000 outstanding minds have a unique story to tell. Join us and contribute to our mission—enabling our customers to make the world healthier, cleaner and safer.
  We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
  Apply today at http://jobs.thermofisher.com

• Provide support for QC Analytical by performing the following: providing technical input for analytical proposals, work statements, test methods, investigations, risk assessments and client inquiries.
• Interpret data in accordance with concepts of biology, microbiology, industry standards, site SOPs and policies.
• Participate in scientifically sound investigations/RCA for related quality events (OOS, deviation, etc.) and design/implement effective CAPA
• Ensure tasks are performed with a method of prioritization - interpret production schedules and complete tasks accordingly
• Identify deviations and aid in investigations. Work to complete documentation of deviations and quality events in appropriate systems
• Participate in client-facing exchanges, 1-1’s, departmental tier meetings, and other meetings/seminars deemed vital to facilitate department needs
• Analyze data and make detailed observations to ensure product quality
• Present data in a coherent manner to various internal and external partners
• Ensure testing is performed in an accurate and timely manner to meet production schedule and project timelines
• Model strong leadership, personal accountability, integrity, and operational excellence