Analyst, QC Microbiologist

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

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.