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Resilience · 1 day ago

Analyst II, Quality Control

West Chester, OH

Full-time

Onsite

Mid Level

$60K/yr - $86K/yr

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. The Analyst II, Quality Control performs routine and non-routine testing of various samples and conducts GMP reviews to ensure compliance with regulatory requirements while supporting continuous improvement in the Quality Control laboratory.

BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical

No H1B

Responsibilities

Performs testing on a range of samples, including chemical 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 Pharmacopeia, British, and Japanese Pharmacopeia

Troubleshoots methods and processes

Leads continuous improvements in laboratory processes

Trains QC employees in GMP, SHE, QC methods and processes

May serve as an expert in a specific area of laboratory equipment, process, or system and supports regulatory audits

This position may require operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment and in a laboratory setting

This role may require collaboration and communication within the team and with operations groups/QA

The role may require individuals to autonomously perform tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site, including data review and on-the-floor sampling

Qualification

HPLCGCGMPChromatography softwareLaboratory equipmentBasic statisticsQuality control terminologyProblem-solving skills

Required

Analytical experience in a GMP facility using various types of instrumentation (HPLC/GC) required, including proficiency with chromatography software (i.e. Empower, etc.)

Proficient in math, laboratory and computer skills. Understand basic statistics and quality control terminology

Working knowledge of laboratory equipment (including HPLC), operations, and safety

Good problem-solving skills