Process Improvement Specialist

Full-time role focused on driving continuous improvement in pharmaceutical manufacturing from formulation through packaging. Collaborate across departments to enhance compliance, efficiency, and right-first-time practices while ensuring adherence to cGMPs, SOPs, and customer requirements.

Responsibilities

• Identify, develop, and implement process improvement initiatives using Lean, Six Sigma, or other continuous improvement tools.
• Solve complex manufacturing problems and drive change in a cross-functional environment.
• Develop metrics for process measurement and identify indicators for future improvement opportunities.
• Support investigations assigned to site Operations and jointly develop CAPAs with area leaders.
• Create, review, and revise Master Batch Records, SOPs, forms, and supporting documentation.
• Promote teamwork, open discussion, and provide coaching/guidance to team members.
• Develop and deliver training for new and existing processes, including GMP training.
• Perform in-process audits to ensure compliance with regulations and written instructions.
• Execute special assignments from the Manager of Production related to process improvement.
• Work effectively in cross-functional teams while maintaining a steadfast quality mindset.

Requirements

• Bachelor of Science or equivalent combination of education and work experience in a related field.
• Excellent oral and written communication skills with strong emotional intelligence and change management aptitudes.
• Proficient in Microsoft Outlook, Excel, Word, and PowerPoint.
• Experience with quality management systems is highly preferred.
• Certification in Six Sigma or a recognized troubleshooting/root cause analysis program.
• Thorough knowledge or ability to learn applicable FDA/cGMP regulations and CFR requirements for drug manufacturing.
• Commitment to a Good Manufacturing Practice culture.
• Ability to meet attendance standards and work a 40-hour week, with occasional additional hours to meet deadlines in a multi-shift operation.
• Compliance with all Company policies, procedures, and safety rules/regulations.

Physical Requirements

• Ability to maneuver at least 50 pounds, climb ladders, and wear required PPE (e.g., safety glasses, ear plugs, safety shoes).
• Ability to wear and pass respirator tests/requirements as needed.

Pay

$27.00 – $36.00/hour