Process Improvement Specialist

2 weeks ago

Athens, Georgia, United States LanceSoft Full time

Position Overview:

The Operations Specialist 3 is a key technical resource responsible for delivering expert support in the manufacturing processes of Active Pharmaceutical Ingredients (API) and medical devices. This role requires collaboration with operations management to ensure compliance with established procedures and regulations.

Key Responsibilities:

  • Provide technical expertise to facilitate investigations of atypical events and nonconformances in production.
  • Monitor and analyze key process parameters, troubleshooting manufacturing issues as they arise.
  • Identify and implement process enhancements to improve efficiency, quality, and cost-effectiveness.
  • Support capital projects and site-wide initiatives as a project lead or subject matter expert.
  • Conduct technical and validation studies to ensure compliance with regulatory standards.

Production Support:

Deliver primary production support on the manufacturing floor. Responsibilities include:

  • Planning and controlling production schedules and material requirements to align with production goals.
  • Facilitating the execution of the production plan and addressing operational challenges.
  • Acting as a subject matter expert, providing guidance on quality-related deviations and investigations.

Process Optimization:

Evaluate existing processes and systems to identify areas for improvement. Collaborate with relevant departments to enhance efficiency and reduce costs.

Implement corrective and preventative measures to improve compliance and mitigate repeat occurrences. Follow up on corrective actions to ensure they effectively address root causes.

Regulatory Compliance:

Ensure adherence to regulatory requirements and technical feasibility of proposed changes. Initiate and manage change controls for projects, utilizing data to monitor process performance and proactively address operational issues.

Collaboration and Innovation:

Work closely with Automation and Information Management teams to enhance process data collection and analysis. Foster a culture of innovation by encouraging new ideas and adapting to change.

Documentation and Training:

Provide support for the revision of Standard Operating Procedures (SOPs) and Batch Records. Review and approve necessary document changes, assist with equipment startup, and deliver technical training as needed.

Qualifications:

Education: High school diploma/GED with two years of formal technical education or equivalent; Bachelor's degree in a science-related field preferred.

Experience: 4-6 years in a regulated manufacturing environment (chemical, pharmaceutical, or medical device). Proficiency in SAP Production and other relevant software is essential.

Skills: Strong analytical and problem-solving abilities, effective communication skills, and the capacity to manage multiple projects. Familiarity with cGMPs and FDA regulations is required.

Physical Requirements: Ability to perform on-site investigations, including gowning procedures for manufacturing environments. Off-shift work and on-call support may be necessary.

Travel: Occasional domestic and international travel may be required.

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