Visual Inspector Trainer

3 weeks ago

Albany, United States Johnson Service Group Full time
Johnson Service Group (JSG) is currently looking for a Visual Inspector Trainer. This is a long-term contracting opportunity with a world leading pharmaceutical company located in Albany, NY.
Hourly Rate up to $60.00
Position Overview:
We are seeking a highly skilled and experienced Visual Inspection Trainer to join our quality assurance team. The ideal candidate will be responsible for training our inspection staff on the detection and categorization of visual defects in sterile injectable drug products, ensuring compliance with regulatory and compendial requirements, and promoting continuous process improvement. This role requires in-depth knowledge of particulate matter, container integrity, and inspection techniques.
Key Responsibilities:
  • Develop and deliver comprehensive training programs on visual inspection processes for injectable drug products.
  • Educate staff on patient risk and the physiological implications of particulates, as well as chemical and microbiological implications.
  • Ensure thorough understanding and adherence to compendial requirements (USP , EP 2.9.20, JP 6.06) and regulatory standards.
  • Train inspectors in manual, semi-automated, and automated inspection methods.
  • Conduct regular requalification and retraining sessions to maintain inspector proficiency.
  • Utilize and manage defect reference manuals and training sets with both good and defective units for practical training.
  • Implement and monitor statistically sound sampling plans for Acceptance Quality Level (AQL) inspection.
  • Address inspection fatigue and ensure optimal inspection conditions are maintained.
  • Provide feedback on inspection results and identify areas for continuous process improvement.
  • Maintain detailed records of training sessions, qualifications, and requalification.
Qualifications:
  • Extensive knowledge of visual inspection processes and standards for injectable drug products.
  • Familiarity with FDA, EMA, and JP guidelines, including recent FDA recall notices and common defect types.
  • Strong understanding of particulate matter classifications: extrinsic, intrinsic, and inherent.
  • Proven experience with various inspection technologies and methods.
  • Ability to train and mentor staff, ensuring clarity and adherence to inspection procedures.
  • Excellent organizational and communication skills.
  • Proficient in developing training materials and conducting practical firsthand training sessions.
Preferred Skills:
  • Experience in a regulated pharmaceutical environment.
  • Knowledge of continuous process improvement and quality control strategies.
  • Strong analytical skills to assess and trend inspection results for adverse trends.
  • Familiarity with creating and managing qualification test kits.
Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
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