Analyst, QC Micro – Lab

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 Brief Job Description The Analyst, QC Micro – Lab performs microbiological testing and quality control activities in support of the site’s microbiological control program.

Core Responsibilities  Perform routine sampling, utility testing, in-process testing, autoclaving, and parts washing in accordance with cGMP  Perform visual inspections and verify materials for correct components, quantities, and characteristics  Monitor equipment and systems for performance and problem indicators; troubleshoot and implement temporary and permanent fixes  Maintain accurate records and archived documentation (laboratory notebooks, logbooks, quality records, sample receipts) per good documentation practices, including periodic logbook reviews  Write, review, and revise SOPs and work instructions for cGMP manufacturing, equipment, systems, and facilities  Analyze data trends to identify root causes, collect and report quality metrics, and recommend corrective actions  Audit SOPs and work instructions to ensure compliance with regulatory requirements; escalate issues outside of SOPs to supervisor or manager  Interact with regulatory agency personnel during audits and inspections  Contribute to compliance, CAPA, and process improvement activities  Train others on systems, equipment, procedures, and SOPs  Serve as an SME cross-functionally; answer compliance and process questions and coordinate with support groups  Communicate policies, procedures, and operational information across employee and management levels  Use CMMS to manage logistics  Experience & Education Minimum Qualifications  Experience performing microbiological testing or analytical laboratory work in a regulated or cGMP environment  Ability to independently apply laboratory skills within own job area, drawing on microbiological knowledge and cGMP experience  Ability to analyze laboratory data, identify trends or deviations, and escalate observations and recommendations to supervisor  Working knowledge of cGMP documentation requirements (logbook practices, deviation identification, SOP compliance)  Ability to prepare clear, accurate technical documentation consistent with cGMP requirements  Preferred Qualifications  Bachelor’s degree in biology, microbiology, or a related discipline  1+ years of experience in a regulated or cGMP laboratory environment  Proficiency with laboratory instrumentation  Working knowledge of cGXP requirements and familiarity with production operations  Proficiency with MS Word and Microsoft Office applications  Knowledge of cGMPs and FDA regulations  Physical & Work Environment  This is primarily a non-sedentary role that can include climbing, kneeling, standing, repetitive motion, temperature changes, exerting up to 100 pounds of force to move objects, and potential exposure to area chemicals requiring handling precautions per SOP.  Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.  Using a computer keyboard, mouse, or other electronic/laboratory device; interpreting sounds and associated meanings at volume levels consistent with interpersonal or group conversations; interpreting letters and numbers when viewed on a computer screen, monitor, reports and other documents; identifying and distinguishing colors.  All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard