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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Position Summary:
This position performs tasks related to the quality of pharmaceutical products in the Microbiology Department. This is a site-based role in West Chester, OH.
This is a Monday - Friday role with weekend on-call support as needed.
Position 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 (i.e., supervisor or 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 (i.e., laboratory notebooks, quality records, and 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 cGMP environment
Experience supporting microbiological testing
Strong technical writing skills and proficiency with MS Word and Office
Preferred Qualifications:
Bachelor's degree in biology, microbiology, or a related discipline.
Proficiency with laboratory instrumentation
Working knowledge of cGXP requirements and a strong familiarity with production operations
This position may also include the following conditions:
This role is primarily non-sedentary. May include but not limited to standing, walking, repetitive motion, and chemical usage. Interpreting sound 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.
The items described here are representative of those that must be met successfully to perform the essential functions of this job.
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 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 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 and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.