QM Associate Scientist

About the role

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 requires a strong understanding of GMP/GDP/GLP regulations and quality management systems.

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.
• Handle 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.
• 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).
• Absorb and investigate out-of-specification (OOS) results, identifying root causes and recommending corrective actions.
• Contribute to the development, review, and revision of SOPs, test methods, and other quality-related documentation.
• Participate in 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.

Requirements

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

Qualifications

• 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.

Skills

• Hands-on laboratory experience.
• Attention to detail.
• Problem-solving skills.
• Effective communication skills.

Benefits

At BD, we offer a comprehensive benefits package designed to support your well-being and financial security. This includes:

• Health insurance options.
• Paid time off.
• Flexible spending accounts.
• Retirement savings plans.
• Employee assistance programs.

Pay

$27.10 - $43.40 USD per hour

Schedule

PR 700am-330pm M-F (United States of America)