Senior Analyst, Quality Control

Resilience • West Chester, OH

19h • $75,000 - $116,250

About The Position

A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Job Summary Senior Analyst, Quality Control will be primarly responsible to perform particulate matter identification testing using FTIR microscopy, write investigation reports, serve as an SME for FTIR microscopy to support investigations and client / regulatory audits. The role requires cross functional collaboration with QC, MSAT, Production and QA.

Requirements

• Analytical chemist experience in a pharmaceutical GMP facility.
• Experience in FTIR spectroscopy techniques.
• Experience using various types of instrumentation (HPLC/GC required, including proficiency with chromatography software such as Empower).
• Proficient in math, laboratory, and computer skills.
• Understand basic statistics and quality control terminology.
• Good problem-solving skills.

Nice To Haves

• Bachelor’s degree in chemistry, biology or related field.
• Bachelor’s degree in chemistry with organic chemistry background.
• FTIR spectral analytical knowledge is a plus.

Responsibilities

• Performs testing on a range of samples, including raw materials, components (including packaging materials), finished products, stability samples, water, and environmental samples.
• Conduct GMP review of laboratory documentation including review of electronic data in a timely manner for compliance with applicable SOPs, test methods, regulations, and protocols.
• Communicate findings to analysts and follow up on corrections.
• Assist in authoring and finalizing departmental SOPs.
• Evaluates data trends and actively participates in the investigation of OOS and atypical events and/or quality issues placing particular attention to root cause analysis, technical completion and scope while ensuring accuracy of documentation contents.
• Provides and follows up on ideas for continuous improvements in laboratory processes.
• Maintains and troubleshoots testing equipment.
• Participates in investigations for PET process areas related to QC processes or data.
• Trains QC employees in good analytical techniques, methods and instrumentation based on expertise.
• Actively support the implementation of compendial changes for raw materials, chemical methods or finished products tests in accordance with applicable Pharmacopoeias such as USP/NF, European Pharmacopoeia, British, and Japanese Pharmacopoeia.
• Troubleshoot methods and processes.

Benefits

• Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level