QA Supervisor LOC : Carmel, NY

QA Supervisor LOC : Carmel, NY

  • Posted on : 09-08-2023
  • Job Type : Full Time only
  • Salary : 100,000 - 200,000

Job Description:

Essential Functions

  • Responsible for m aintaining, evaluating and improving the Carmel site Quality Systems and all associated documentation.
  • Responsible for the review and approval of Batch Records.
  • Monitor metrics or KPIs and communicate information and recommendations to Site Quality Head.
  • Manage the Carmel site internal auditing program and perform internal audits.
  • Perform effective and timely investigations of Complaints. Determine root causes and suggest appropriate CAPAs. Manage the Complaint system.
  • Manage the Annual Product Review program; ensure that APRs are completed in a timely fashion.
  • Perform effective and timely investigations of deviations. Determine root causes and suggest appropriate CAPAs. Manage the Investigations system.
  • Manage the CAPA program, ensure that CAPAs are completed in a timely fashion.
  • Approve incoming printed materials in the SAP system.
  • Communicate with other departments to provide support and to coordinate activities.
  • Identify and design new systems or programs to remain current with industry compliance trends regarding liquid dosages and components, environmental monitoring, cleaning validation, risk assessments, etc.
  • Handle personnel responsibilities including payroll / attendance, performance reviews, disciplinary action, goals/objectives, rewards, coaching, training, etc.
  • Appropriately document employees performance and provide corrective actions or training.
  • Assist in the development and presentation of cGMP training to all employees.
  • Assist in special projects or other tasks as deemed necessary based on personal qualifications, business needs and QA managements discretion.

Training Or Experience

  • At least 5 years of quality assurance experience in a GMP-regulated pharmaceutical manufacturing site.
  • Prior supervisory experience required, prefer at least two years of supervisory experience.
  • Knowledge of GMP, USP/NF, ICH, and FDA guidelines and regulations.
  • Excellent oral and written communication skills.
  • Expertise in Microsoft Word and Excel, knowledge of SAP preferred.
  • Strong troubleshooting and investigation skills.
  • Demonstrated ability to work as part of a cross-functional team.

Education

  • Minimum of a BS Degree
  • Supervises/Manages
  • Supervise QA Inspectors


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