Analyst 2 - QC Microbiology

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

The Analyst II, QC Micro – Lab performs microbiological testing of raw materials, in-process and finished product, stability, utility, and environmental samples in support of a sterile pharmaceutical manufacturing site. Working with limited supervision, the role self-directs testing and documentation activities across short- and long-term priorities, reviews data and records for trends and cGMP compliance, and leads investigations and process improvement activities within its scope. The role serves as a technical resource for laboratory methods, equipment, and systems and supports the training and technical development of QC Microbiology team members.

Job Responsibilities

Laboratory Testing & Data Review

• Maintain qualification to perform microbiological testing, including gowning and aseptic technique required for sampling in classified areas
• Perform and document testing on raw materials, in-process and finished products, stability samples, water, gas, and environmental samples
• Verify and review test data, logbooks, and documentation for accuracy, completeness, and cGMP compliance
• Identify data trends, determine root causes, and recommend solutions or improvements
• Collect, record, and report metrics

Investigations & Quality Records

• Lead or participate in investigations involving QC processes or data with limited supervision
• Author quality records including deviations, CAPAs, and change controls
• Escalate problems occurring outside of SOPs to the supervisor
• Lead or participate in process improvement activities within the laboratory

Methods, Equipment & Systems

• Troubleshoot laboratory methods, equipment, and processes
• Monitor equipment and systems for performance and problem indicators
• Author, review, and revise SOPs, work instructions, and documentation supporting cGMP manufacturing of commercial product
• Use MAXIMO or CMMS to manage laboratory logistics and equipment work orders
• Coordinate qualification activities for laboratory methods and equipment

Training, SME & Audit Support

• Train team members on laboratory methods, equipment, systems, and procedures
• Communicate operational priorities and information to the team
• Consult cross-functionally as an SME on systems and processes within the functional area
• Interact with regulatory agency personnel during audits and inspections
• Recommend compliance solutions to management

Experience & Education

Minimum Qualifications

• In-depth working knowledge of cGXP requirements and production operations, with the ability to self-direct testing and documentation activities across short- and long-term priorities
• Ability to independently identify root causes, evaluate options, and determine corrective actions within scope
• Experience as a skilled specialist performing microbiological testing in a cGMP laboratory, including authorship of deviations, CAPAs, and change controls
• Proficiency with laboratory instrumentation and technical writing sufficient to complete complex tasks effectively
• Experience training and providing technical guidance to others on laboratory methods, equipment, and systems
• Demonstrated ability to work with limited supervision on routine tasks and to complete complex assignments independently within own role

Preferred Qualifications

• Bachelor’s degree in biology, microbiology, or related discipline
• 2+ years of laboratory experience in the pharmaceutical industry
• Prior experience supporting microbiological testing in a sterile pharmaceutical operation
• Working knowledge of electronic data management systems such as MODA and Labware LIMS

Physical & Work Environment

• This is primarily a non-sedentary role.
• Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.
• Occasional (20–60% of time): sitting, walking, and monitoring other people's work.
• Infrequent (<20% of time): lifting/carrying up to 30 lbs., working at heights of 5 ft., bending, stooping, twisting, reaching, noise exposure, operating moving machinery, chemical usage with potential exposure to area chemicals requiring handling precautions per SOP, traveling, and speaking publicly.
• 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; seeing with 20/20 (or better) vision, with or without correction.
• 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

8 hours - Monday- Friday

Available to provide 24/7 on call support when requested.
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 $60,000.00 - $86,250.00 per year. 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.