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.
Job Responsibilities
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 Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.
Work Schedule: Monday - Friday with some on - call support
The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. This role requires the ability to provide 24/7 on-call support as needed.
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 $24.00 - $34.50 per hour. 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.
