Resilience

Senior Analyst, QC Microbiology

USA - OH - West Chester · Senior · Contract

Work authorization required$75k-$116kDetected 57 days ago

Process ImprovementHRISGMPLeadershipCommunicationProblem SolvingMentoring

About the role

This position also authors SOPs and serves as a subject matter expert for the EDMS system.

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.
Maintains and troubleshoots testing equipment.
Actively support and/or lead 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.
Provide support in coordinating activities in the laboratory.
Perform logbook reviews.
Lead process improvement activities and teams to meet strategic goals.
Use MAXIMO and/or CMMS (Computerized Maintenance Management System) to manage logistics.
Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions.
Interact with other departments to implement corrective/preventative actions.
Nothing in this description creates a guarantee of specific hours, days, or

Prior experience in a regulated GMP environment.
Working knowledge of cGXP requirements and a strong familiarity with production operations.
Completes required training and trains QC employees in GMP, SHE, QC methods and processes.
As well as, good aseptic techniques, and instrumentation based on expertise.
Demonstrates expertise on authoring Quality records (Deviations, CAPAs, and Change Controls).

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.
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.
The items described here are representative of those that must be met successfully to perform the essential functions of this job.

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 healt

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

This listing is sourced directly from Resilience's careers page and normalized into a canonical job model.