Analyst, QC Microbiologist

RESILIENCE (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives. For more information, visit www.resilience.com Position Summary and Responsibilities: Prepare documentation of activities, actions, and/or results. Read SOPs (Standard Operating Procedures) and excerpts from technical documentation. Complete required training. Ensure proper documentation practices during job activities. Perform visual inspections. Verify count, measure and check materials to ensure proper components, quantities, and/or characteristics. Conduct troubleshooting activities. Train others on systems, software, equipment, machines, procedures, and/or processes. Answer compliance and process questions from others. Communicate policies and procedures to employees. Gather, organize, and communicate operational information to others. Facilitate communication between management and non-management. Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions. Assist with coordinating activities of support groups. Analyze trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or improvements. Identify temporary and permanent fixes to address issues. Monitor records to ensure compliance with regulatory requirements. Coordinate with representatives from other departments. Alert others (for example: supervisor, manager) when problems occur outside of SOPs (Standard Operating Procedures). Attend team meetings to discuss progress, initiatives, and/or other matters. Collect, record, and report metrics. Monitor equipment and/or systems for performance and problem indicators. Perform data entry. Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities. Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area. Ensure that others carry out laboratory duties in a manner consistent with cGMP. Maintain accurate and complete records (for example: laboratory notebooks, quality records, sample receipts). Maintain archived records and documentation. Perform logbook reviews. Provide feedback on service and quality issues on a timely basis. Lead process improvement activities and teams to meet strategic goals. Use CMMS (Computerized Maintenance Management System) to manage logistics. Interact with regulatory agency personnel during audits and inspections. Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions. Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product. Write, review, and revise SOPs (Standard Operating Procedures) for maintenance of equipment, systems, and/or facilities. Author, review, and revise documentation needed for cGMP (Good Manufacturing Practices) manufacturing of commercial product. Interact with other departments to implement corrective/preventative actions. Participate in cross-functional teams to meet strategic goals. Assess and implement improvements in productivity, waste generation, quality and cost. Perform routine sampling activities. Performing utility testing Perform autoclaving and parts washing. Perform in-process testing. Provide 24/7 "on-call" support to others, as required Recommend compliance resolutions to management. Minimum Qualifications: Experience in a regulated or cGMP environment. Experience supporting microbiological testing in a sterile pharmaceutical operation environment. Proficiency in solving complex problems and elucidating root causes for investigations. Strong technical writing skills, proficiency with MS Word and Office Preferred Qualifications: Bachelor’s degree in biology, Microbiology or related discipline Proficiency with laboratory instrumentation Working knowledge of cGXP requirements and a strong familiarity with production operations. Working knowlegde of LIMS, LabVantage, or other sample management system Working knowledge of MODA, Novatek, or other sample management system This position may also include the following: 1. Physical work - This role primarily a non-sedentary role and includes lifting, working at heights, sitting, standing, walking, bending, stooping, twisting, reaching, repetitive motion, noise exposure, chemical usage, visual and auditory acuity, and wearing personal protective equipment. 2. Quality Statement: All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role. Resilience offers employees a robust total rewards program including equity, 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, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $60,000.00 - $75,000.00. 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 and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters. RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives. Please Note – Resilience does not accept unsolicited agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience. Culture Focus Sites

Salary : $60,000 - $0