Senior Analyst, Quality Control

Location: West Chester

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.

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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.

Position 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.

Minimum Qualification:

• 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.

Preferred

Qualification:

• 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.

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws.

Requests for reasonable accommodation can be made at any stage of the recruitment process.

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.

Our target base pay hiring range for this position is $75,000.00 - $ per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.

Required

Preferred

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