Analyst II, QC Microbiology

Resilience; Olde West Chester (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

Resilience is seeking an Analyst II in QC Microbiology to support testing of raw materials, in-process and finished products, stability and environmental samples, while ensuring cGMP compliance.

You will write and revise SOPs, participate in investigations, and mentor others as needed. A Bachelor's in biology or microbiology and at least 2 years in pharma labs are preferred. The role requires standing and PPE usage.

Qualifications

• Working knowledge of cGXP requirements and familiarity with production operations.
• Good problem-solving skills.
• Adherence to the Quality Management System (QMS) and applicable regulations.
• Position is primarily non-sedentary; may involve standing, walking, and PPE use.
• Sponsorship or work authorization visas not available.

Responsibilities

• Read SOPs and technical documentation.
• Write, review, and revise SOPs and work instructions for cGMP manufacturing.
• Complete required training and may train others.
• Conduct troubleshooting activities and collect operational data.
• Gather and communicate information; facilitate team meetings.
• Participate in investigations related to QC processes or data; assist with coordinating support groups.
• Identify data trends, root causes, and improvements; author deviations, CAPAs, and change controls.
• Lead or participate in process improvement activities; use MAXIMO/CMMS for logistics.
• Interact with regulatory agencies during audits and inspections; coordinate qualification activities.

Skills

cGXP knowledge

Problem solving

Education

Bachelor's degree in biology or microbiology

Job description

Position Summary

The Analyst II, QC Microbiology role supports the Microbiology Department by performing quality‑related tasks for pharmaceutical products, including documenting and conducting testing on a variety of samples such as raw materials, in‑process and finished products, stability samples, water, gas, and environmental samples.

Job Responsibilities

• Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
• Write, review, and revise SOPs and work instructions for cGMP manufacturing.
• Complete required training and may train others.
• Conduct troubleshooting activities.
• Gather, organize, and communicate operational information.
• Facilitate team meetings to discuss progress, initiatives, and other matters.
• Participate in investigations involving manufacturing process areas, related to QC processes or data, such as sampling, deviations potentially affecting QC results, investigational sampling, and testing.
• Assist with coordinating activities of support groups.
• Identify trends in data to provide accurate descriptions, identify root causes, and identify solutions or improvements.
• Author quality records (Deviations, CAPAs, and Change Controls).
• Identify temporary and permanent fixes to address issues.
• Alert supervisor or manager when problems occur outside SOPs.
• Collect, record, and report metrics.
• Monitor equipment and/or systems for performance and problem indicators.
• Wear gowning, sterile garments, and PPE as required by specific activities.
• Consult cross‑functionally as an SME on systems and/or processes within a functional area.
• Perform logbook reviews.
• Lead or participate in process improvement activities and teams to meet strategic goals.
• Use MAXIMO and/or CMMS to manage logistics.
• Interact with regulatory agency individuals during audits and inspections, when necessary.
• Author, review, and revise documentation needed for cGMP manufacturing.
• Attend inter‑departmental meetings to discuss coordination of multiple departments.
• Coordinate qualification activities.
• Perform routine sampling activities on facility utilities.
• Recommend compliance resolutions to management.

Minimum Qualifications

• Working knowledge of cGXP requirements and strong familiarity with production operations.
• Good problem‑solving skills.
• All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, SOPs, cGMP, and other applicable regulations.
• Position is primarily non‑sedentary; may include standing, walking, repetitive motion, and chemical usage.
• Maintaining compliance with the Quality Management System.
• Sponsorship or support for work authorization, including visas, is not available for this position.

Preferred Qualifications

• Bachelor’s degree in biology, microbiology, or related discipline.
• At least 2 years of laboratory experience in the pharmaceutical industry.
• Prior experience supporting microbiological testing in a sterile pharmaceutical operation environment.

Benefits

The role offers a total rewards program including an annual cash bonus program, a 401(k) plan with generous company match, and a benefits package designed to support employees with healthcare (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.

Recruitment Information

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or other non‑job‑related characteristics as required by applicable laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.