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Quality Assurance Inspector

2 months ago


New York, New York, United States Contract Pharmacal Full time
Job Title: Inspector, QA Manufacturing

Contract Pharmacal is seeking a highly motivated and detail-oriented Inspector, QA Manufacturing to join our team. As a key member of our quality assurance team, you will be responsible for ensuring product quality is maintained through all phases of manufacturing in accordance with current good manufacturing practices.

Responsibilities:
  • Perform in-process monitoring of all manufacturing operations, including weight, thickness, hardness, disintegration, friability, and other relevant parameters.
  • Collect in-process and finished product samples as required, and support the collection of microbiological samples per procedure.
  • Perform room inspections and clearances as needed, and ensure that all documentation is accurate and complete.
  • Release batch records for both commercial and IP batches, and perform AQL sampling and inspections as required.
  • Identify and report any non-conformances or discrepancies to management, and review general SOPs to ensure compliance.
  • Assist in employee training and support environmental monitoring activities, including water and air sampling.
  • Provide additional QA technical support to the Coating Department, and review batch record documentation.
  • Issue QMS forms as required to production, and maintain QA supplies.
  • Review and approve weekly pest control logs, and sample transmittal to QC and Account Services.
  • Review grounds logbook for Maintenance, and perform monthly audits of facility fire extinguishers.
Requirements:
  • High School or GED diploma required.
  • Knowledge of good manufacturing practices and good documentation practices preferred.
Skills and Abilities:
  • Ability to read, write, and communicate effectively.
  • Self-motivated with the ability to work in a fast-paced environment and handle multiple tasks simultaneously.
  • Excellent organizational skills with the ability to focus on details.
Work Environment:

The work environment in production operations facilities includes close proximity to heavy machinery with loud noises and pharmaceutical powders (dust). The potential to move between production operations sites/areas to complete job functions is also a requirement.

Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion. Work location is subject to change as needed to meet business requirements.