Analyst II, QC Aseptic Control, Lead (Night Shift)

Resilience•West Chester, OH

3d•$60,000 - $86,250•Onsite

About The Position

The Analyst II, QC Aseptic Control, Lead autonomously performs tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. This includes operating equipment in various classified/non-classified areas up to a Grade A aseptic environment and in a laboratory setting and maintaining gowning qualification. In addition, the incumbent will perform tasks related to scheduling work and loads, reviewing sampling and lab data, performing project work, leading laboratory investigations, and training and coaching colleagues.

Requirements

Prior experience in a pharmaceutical production or quality control environment
Ability to effectively understand, read, write, communicate and follow instructions in the English language
Thorough attention to detail because individual must be capable of keeping accurate records and performing mathematical calculation

Nice To Haves

Bachelor’s degree in scientific discipline
Prior experience in a sterile or cGxP environment

Responsibilities

Schedule work and load the correct pulls in Environmental Monitoring System
Troubleshoot methods and processes
Develop methods and processes
May serve as the primary link between QC team and Operations for day-to-day activities, such as schedules and workload planning
Coordinate workflow in Environmental Monitoring team
Verify QC data while monitoring for trends and abnormalities
Maintain training to perform all Environmental Monitoring technician responsibilities (including maintaining aseptic qualification) when needed
Review completed production documentation (for example: logbooks) for quality, completeness, and cGMP (Good Manufacturing Practices) compliance
Assign work tasks and activities to others
Perform logbook reviews
Train others on systems, software, equipment, machines, procedures, and/or processes
Answer compliance and process questions from others
Communicate policies and procedures to employees
Fill in for immediate supervisor when needed
Gather, organize, and communicate operational information to others
Lead and coordinate investigations and studies with little supervision
Lead process improvement activities and teams to meet strategic goals
Communicate priorities and progress to team on a continuing basis
Ensure that employees have the tools needed to perform their jobs
Monitor training of employees to ensure compliance
Perform other duties that support Environmental Monitoring, Operations, or Laboratory Processes