Analyst II, Quality Control (Night Shift)

Resilience•West Chester, OH

5d•Onsite

About The Position

The Analyst II, Quality Control conducts on-the-floor sampling, data review, and documentation in compliance with cGMP standards. The role tests a variety of samples, including finished products, raw materials, stability samples, in-process materials, and water systems. It requires attention to detail, adherence to quality standards, and the ability to work autonomously in a regulated manufacturing and laboratory environment. The position may involve operating equipment in classified and non-classified areas, including a Class 100 (ISO 5) aseptic environment, and collaborating with team members and operations groups or QA. The role may also include autonomous environmental-monitoring activities to support regulatory requirements at a sterile manufacturing site. Work is onsite and requires cleanroom gowning and adherence to aseptic behavior requirements during cleanroom activities. The expected schedule is a rotating 12-hour night shift from 6:00 p.m. to 6:30 a.m.: two nights on, two nights off, three nights on, three nights off, then repeating. Weekend and holiday work is scheduled as needed. The role may require overtime and 24/7 on-call support as needed. Work authorization or visa sponsorship is not available.

Requirements

Working knowledge of cGXP requirements and strong familiarity with production operations.
Good problem-solving skills.
Proficiency in math, laboratory skills, and computer skills.
Understanding of basic statistics and quality control terminology.
Good verbal, written, interpersonal, and organizational skills.
Ability to work autonomously in a regulated environment and adapt quickly to new priorities or situations.
Ability to safely handle hazardous materials.
Ability to work onsite in a cGMP manufacturing and laboratory environment, including cleanrooms classified up to Class 100 (ISO 5), and comply with gowning and aseptic behavior requirements.
Ability to stand, walk, bend, and reach for extended periods and lift up to 25 pounds.
Ability to work a rotating 12-hour night shift, including weekends and holidays as scheduled, and provide 24/7 on-call support as needed.

Nice To Haves

Bachelor’s degree in chemistry, biology, or a related field.
QC chemistry laboratory experience in the pharmaceutical industry.
Working knowledge of laboratory equipment, including HPLC, operations, and safety.

Responsibilities

Perform testing on finished products, raw materials, stability samples, in-process materials, and water samples.
Maintain and troubleshoot testing equipment.
Support laboratory investigations and QC method and SOP updates.
Execute laboratory test protocols supporting development and validation activities.
Review QC data.
Provide and follow up on ideas for continuous improvement in laboratory processes.
Handle hazardous materials safely and knowledgeably.
Perform environmental-monitoring tasks, including data review and on-the-floor sampling, as needed to support regulatory requirements.
Collaborate and communicate with the team, operations groups, and QA.
Complete assigned work independently when appropriate, while accepting direction and correction when learning procedures and performing analysis.
Contribute to a collaborative team environment and adapt to changing priorities or situations.