Operational Excellence Analyst

Job Title:

Operational Excellence Analyst Location:

Philadelphia, PA (On-site)

Job Type:

Full-time Schedule:

Monday-Friday, 7:30 AM - 4:00 PM (may vary based on business needs)

Salary:

$60,000+

Awesome Benefits Start Date:

ASAP No C2C | No OPT Overview We are seeking an Operational Excellence Analyst to support a pharmaceutical manufacturing environment. This role focuses on process improvement, deviation investigations, and ensuring compliance with FDA and cGMP standards. Key Responsibilities Review, update, and maintain Standard Operating Procedures (SOPs) and process documentation Investigate production nonconformances and support deviation management Perform root cause analysis using tools such as 5-Why and Fishbone (Ishikawa) Lead and support CAPA (Corrective and Preventive Actions) activities Collaborate with cross-functional teams including Quality, Operations, Engineering, Maintenance, and Facilities Ensure investigations are thorough, timely, and compliant with cGMP and internal quality systems Identify recurring issues and support continuous improvement initiatives Oversee documentation related to equipment calibration and preventive maintenance programs Support additional operational projects as assigned Qualifications Bachelor's degree in engineering, Science, or a related field Minimum 1 year of experience in an FDA-regulated manufacturing environment (Pharmaceuticals, Medical Devices, or Food industry) Working knowledge of FDA regulations, cGMP, Good Documentation Practices (GDP), and Change Control Experience with CAPA, deviation investigations, and root cause analysis Strong analytical, problem-solving, and organizational skills Proficiency in Microsoft Office and quality system applications Ability to analyze and communicate complex technical information Additional Skills and Competencies Strong attention to detail and critical thinking Ability to manage multiple priorities and meet deadlines Effective communication and collaboration skills Professional approach with the ability to work in a fast-paced environment

Pay:

From $60,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Application Question(s): Do you have at least 1 year of experience in an FDA-regulated manufacturing environment (pharmaceutical, medical device, or food) with working knowledge of cGMP, GDP, change control, and experience in CAPA, deviations, and root cause investigations? Ability to

Commute:

Philadelphia, PA 19116 (Required)

Work Location:

In person