Senior Analyst, QC Microbiology

Resilience; Olde West Chester (OH); On-site; USD 75,000 - 116,250; Full time

Benefits offered by this job

Annual cash bonus program

401(k) plan with company match

Healthcare benefits (medical, dental, vision)

Job summary

Resilience is seeking a Senior Analyst, QC Microbiology in Olde West Chester, Ohio. The role involves performing microbiological testing on materials and products, ensuring GMP compliance, and leading investigations in laboratory processes.

The ideal candidate will have significant experience in QC Microbiology within a regulated environment and a Bachelor's degree in a related field.

Benefits include a robust rewards program, healthcare support, and education reimbursement.

Qualifications

• Prior experience in a regulated GMP environment.
• Strong familiarity with production operations.
• 5 years QC Microbiology laboratory experience preferred.

Responsibilities

• Perform microbiological testing and document results.
• Lead investigations involving QC processes.
• Support continuous improvements in laboratory processes.
• Serve as a subject matter expert during inspections.

Skills

Attention to details

Problem-solving skills

Knowledge of cGXP requirements

Education

Bachelor's degree in a Science subject

Job description

Position Summary

The Senior Analyst, QC Microbiology performs and documents microbiological testing on raw materials, in-process and finished products, and environmental samples. The role ensures GMP compliance through timely review of laboratory data and documentation, communicates findings, and supports corrections. This position also authors SOPs and serves as a subject matter expert for the EDMS system.

Position Responsibilities

• Evaluates data trends and authors reports associated with trends.
• Leads and/or actively participates in investigations involving manufacturing process areas, related to QC processes or data, such as sampling, deviations potentially affecting QC results, investigational sampling, and testing.
• Provides and follows up on ideas for continuous improvements in laboratory processes.
• Maintains and troubleshoots testing equipment.
• Completes required training and trains QC employees in GMP, SHE, QC methods and processes, good aseptic techniques, and instrumentation based on expertise.
• Actively supports and/or leads the implementation of compendial changes for raw materials, in-process or finished products tests in accordance with applicable Pharmacopoeias such as USP/NF, European Pharmacopeia, British, and Japanese Pharmacopeia.
• Troubleshoots methods and processes.
• May serve as an expert in a specific area of laboratory equipment, process, or system.
• Serves as a subject matter expert during regulatory inspections, including potential demonstrations and inspection room discussions.
• Demonstrates expertise on authoring Quality records (Deviations, CAPAs, and Change Controls).
• Answers and guides others in documentation, compliance, and other process questions.
• Gathers, organizes, and communicates operational information to others.
• Facilitates communication between management and non‑management and team meetings.
• Provides leadership, development, and mentoring for others.
• Provides support in coordinating activities in the laboratory.
• Identifies temporary and permanent fixes to address issues.
• Coordinates with representatives from other departments.
• Attends team meetings to discuss progress, initiatives, and/or other matters.
• Collects, records, reports, and trends metrics when applicable.
• Wears gowning, sterile garments, and PPE as required by specific activities.
• Consults cross‑functionally as an SME on systems and/or processes within a functional area.
• Performs logbook reviews.
• Leads process improvement activities and teams to meet strategic goals.
• Uses MAXIMO and/or CMMS to manage logistics.
• Alerts supervisor or manager when problems occur outside of SOPs.
• Performs regular audits of SOPs and/or work instructions.
• Reviews and approves documentation needed for qualification of equipment and processes.
• Attends and facilitates inter‑departmental meetings to discuss matters involving the coordination of multiple departments when necessary.
• Interacts with other departments to implement corrective/preventative actions.
• Reviews and approves quality records as an SME when required.
• Provides off‑shift support (i.e., night shift support if you normally workday shift).
• Coordinates qualification activities.
• Assesses and implements improvements in productivity, waste generation, quality and cost.
• Recommends compliance resolutions to management.

Minimum Qualifications

• Prior experience in a regulated GMP environment.
• Working knowledge of cGXP requirements and a strong familiarity with production operations.
• Excellent attention to details and problem‑solving skills.

Preferred Qualifications

• Bachelor's degree in a Science subject (Microbiology, or closely related subjects).
• 5 years QC Microbiology laboratory experience.
• High level knowledge and competence with a specific piece of laboratory equipment, or a QC/QA process or system.
• Prior experience supporting microbiological testing in a sterile pharmaceutical operation environment.

Hours

Day Shift: Sunday - Wednesday 10 hour shift.

Benefits

Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match, and a benefits package thoughtfully designed to support employees with healthcare (medical, dental, vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.

Salary

Target base pay hiring range: $75,000.00 - $116,250.00 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.

Work Authorization

Sponsorship or support for work authorization, including visas, is not available for this position.

Equal Employment Opportunity

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.

Reasonable Accommodation

Requests for reasonable accommodation can be made at any stage of the recruitment process.