Associate Analyst QC (2nd Shift)

Johnson & Johnson - Malvern, PA

Full-time - Entry Level

Malvern, PA

5,001-10,000 employees

Chemical Manufacturing

About the position

The QC Analyst, Microbiology position at Johnson & Johnson is responsible for supporting the Quality Control Microbiology laboratories by conducting microbiological testing of raw materials, in-process, or final product samples. This role emphasizes compliance with applicable procedures, standards, and GMP regulations, requiring a high level of attention to detail and analytical skills. The position involves working in a team environment and contributing to continuous improvement initiatives within the laboratory.

Responsibilities

• Perform analytical testing in compliance with applicable GMP regulations while maintaining a safe work environment.
• Conduct biochemical, microbiological, and/or general chemical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
• Perform peer review of laboratory data.
• Use electronic systems (LIMS, MES, LES, Empower, Trackwise, etc.) for execution and documentation of testing.
• Maintain Laboratory Housekeeping including sample management, reagent prep, instrument standardization/calibration.
• Complete Document Revisions.
• Maintain individual training completion in a compliant state and train new laboratory personnel.
• Participate in continuous improvement initiatives.
• Complete CAPAs when required for the Quality Control organization.
• Maintain Laboratory in audit ready state and participate in internal and Health Authority inspections.
• Provide input to functional laboratory meetings.

Requirements

• Minimum of a Bachelor's degree in a life science is required.
• Minimum of 1 year of proven experience is preferred.
• Experience with basic laboratory skills and some experience/knowledge of analytical methodologies (Spectroscopy, bioburden, endotoxin, pH, etc.) is preferred.
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems is required.
• Knowledge and awareness of compendial (USP, EP, JP, etc.) requirements and standards for QC testing is preferred.
• Basic knowledge of Johnson & Johnson Quality and Compliance standards is preferred.
• Detailed knowledge and experience in applying statistical concepts to laboratory data is preferred.
• Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols is required.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint) is required.

Nice-to-haves

• Knowledge and awareness of compendial (USP, EP, JP, etc.) requirements and standards for QC testing is preferred.
• Basic knowledge of Johnson & Johnson Quality and Compliance standards is preferred.
• Detailed knowledge and experience in applying statistical concepts to laboratory data is preferred.

Benefits

• Diversity, equity, and inclusion initiatives
• Career development opportunities
• Health and wellness programs