Process Technician - QA Visual Inspection

Role Summary

The Process Technician - QA Visual Inspection works as a member of the Statistical Sorting team and reports to the Sr. Manager- QA Visual Inspection. Responsibilities include performing AQL inspections, final classification of defects, sample management as well as providing QA oversight to GMP operations in the Parenteral visual inspection areas which includes automated visual inspection, semi- automated inspection, and manual inspection. The QA Visual Inspection Technician oversees visual inspection production functions to achieve patient safety and site goals through effective quality oversight. This position is based in Raleigh-Durham, North Carolina.

Responsibilities

• Ensures regular presence in assigned parenteral areas to perform AQL inspections, manage sample collection/deliver to laboratories.
• Responsible for adhering to safety rules and maintaining a safe work environment for yourself and others by supporting HSE corporate and site goals.
• Responsible for ensuring training is completed and remains in compliance.
• Communicates with QA Representative and Sr. Manager- QA Visual Inspection on quality and operational issues.
• Ensures adherence and understanding of good documentation practices and compliance with applicable procedures.
• Advise Visual Inspection Operations and support personnel on quality matters, while driving the site Quality culture.
• Execution of activities in electronic batch record (PMX), laboratory LIMS system (Darwin), and other systems as required (SAP, TrackWise).
• Participate in self-led inspections and provide support during internal / external regulatory inspections.

Qualifications

• Required: High School Diploma or equivalent
• Required: Demonstrated experience in GMP facility
• Required: Legally authorized to be employed in the United States (no visa sponsorship anticipated)
• Required: Must pass a vision exam and be free of color blindness
• Required: 20/20 correctable close vision acuity
• Preferred: Parenteral Inspection experience (automated, semi-automated and manual)
• Preferred: Associate degree in a science, engineering, computer, or pharmaceutical related field
• Preferred: Strong understanding of quality systems in the inspection environment
• Preferred: Strong oral and written communication and interpersonal skills
• Preferred: Knowledge of pharmaceutical processes and Quality Systems
• Preferred: Strong attention to detail and organizational skills
• Preferred: Basic computer skills (Microsoft Office, SAP, PMX)
• Preferred: Ability to work cross-functionally and collaboratively
• Preferred: Ability to work independently or as part of a team to resolve issues

Skills

• Quality systems and GMP knowledge
• Communication and interpersonal skills
• Attention to detail and organizational skills
• Proficiency with Microsoft Office, SAP, and electronic batch records (PMX)
• Ability to work cross-functionally and in a team

Additional Requirements

• Ability to work 12-hour shifts on days (2-2-3 schedule).
• Ability to work overtime, as requested.
• Ability to wear safety equipment and follow gowning requirements.
• Physical Demands: Light work requiring physical effort; good eye-hand coordination and manual skills; occasional lifting, bending, climbing, and walking stairs.