QM Associate Scientist

Becton Dickinson Medical Devices•Hunt Valley, MD

5h•Onsite

About The Position

The QM Associate Scientist will perform various laboratory testing, data analysis, and documentation activities to ensure product quality and compliance with regulatory standards. This role involves executing routine and non-routine quality control (QC) testing on raw materials, in-process samples, and finished products according to established Standard Operating Procedures (SOPs) and specifications. The position may require handling hazardous materials, including chemicals and infectious agents, and potentially performing testing in a Biosafety Level 3 Laboratory containment environment for organisms like Mycobacterium tuberculosis (TB). The role also includes working in a clean room environment, operating and maintaining laboratory equipment, documenting results, assisting in OOS investigations, and participating in the development of quality-related documentation. Collaboration with cross-functional teams and flexibility to work in different QC laboratories without permanent assignment are also key aspects of this position.

Requirements

Minimum of laboratory related certificate from accredited institution required.
Strong understanding of GMP/GDP/GLP regulations and quality management systems.
Excellent written and verbal communication skills.
Strong attention to detail and ability to maintain accurate records.
Ability to work independently and as part of a team in a fast-paced environment.
Good problem solving and trouble-shooting skills.

Nice To Haves

Bachelor's degree in Biology, Microbiology or other related Life Science preferred.
Minimum of one year practical experience in Microbiological or medical technology laboratory preferred.

Responsibilities

Execute routine and non-routine quality control (QC) testing on raw materials, in-process samples, and finished products according to established Standard Operating Procedures (SOPs) and specifications.
Handling of hazardous materials, including chemicals and infectious agents, in the accurate manner as established by safety and company policy.
May be required to perform testing of Mycobacterium tuberculosis (TB) and other similar organisms requiring Biosafety Level 3 Laboratory containment with strict adherence to safety policies associated with this manner of testing.
Able to work in a clean room environment meeting validation requirements associated with donning and doffing cleanroom suits, gloves, mask, and other PPE correctly and consistently.
Operate and maintain laboratory equipment, including calibration and troubleshooting, and ensure all equipment is in good working order.
Document all results and observations accurately and thoroughly on test sheets and electronic systems (SAP).
Assist in the investigation of out-of-specification (OOS) results, identifying root causes and recommending corrective actions.
Participate in the development, review, and revision of SOPs, test methods, and other quality-related documentation.
Contribute to continuous improvement initiatives within the quality management system.
Ensure compliance with all applicable Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Good Laboratory Practices (GLP), and company policies.
Collaborate effectively with cross-functional teams, including manufacturing and scientific ops.
Will work in any of the laboratories within the QC department without a permanent assignment.