Unclassified

posted 4 months ago

Full-time

About the position

The Technical Operations Specialist at PCI Pharma Services plays a crucial role in ensuring the quality and compliance of finished goods produced by the company. This position is responsible for performing release testing on these products, meticulously documenting the results, and confirming that they meet the predetermined specifications outlined in relevant documentation. The Specialist will interact with various departments to facilitate the testing process, ensuring that all quality standards are upheld throughout the operation. In this role, the Specialist must understand and execute all activities within the Quality Technical Operations Department. This includes maintaining accurate release testing records and procedures in alignment with the company's Quality Management System, as well as adhering to federal, state, and regulatory requirements. The Specialist will be tasked with recording inspection results and making material disposition decisions according to approved company processes. Accuracy in processing material transactions is essential to ensure a smooth release process. Teamwork is a vital aspect of this position, as the Specialist must actively participate and collaborate with colleagues to enhance the overall quality of processes. They will represent the Quality department on assigned project teams, leading quality-related projects to successful completion. Proactive follow-up is necessary to secure any missing documentation, ensuring that all quality expectations are met and expediting the testing of materials. The Specialist will also engage with customers to address any quality-related inquiries in a professional manner. The position may require overtime and weekend work, and adherence to PCI's cGMP and GCP policies is mandatory. Attendance is considered an essential function of this role, and the Specialist may be assigned additional duties by their Manager or Supervisor as needed.

Responsibilities

  • Perform release testing on finished goods to ensure compliance with specifications.
  • Maintain release testing records and procedures in accordance with the Quality Management System.
  • Record inspection results and manage material disposition according to company processes.
  • Accurately process all material transactions throughout the release process.
  • Actively participate in team efforts to improve overall quality of processes.
  • Represent the Quality department on project teams and lead quality-related projects.
  • Proactively follow up to secure missing documentation for quality compliance.
  • Interact with customers to address quality-related questions professionally.
  • Follow established Standard Operating Procedures (SOPs).
  • Perform other duties as assigned by Manager/Supervisor.

Requirements

  • High school education or at least 2 years of experience in pharmaceutical, scientific, or pharmaceutical packaging.
  • Excellent organizational, time management, and multi-tasking skills.
  • Knowledge of basic product release testing processes.
  • Strong problem-solving skills and attention to detail.
  • Basic understanding of cGMP requirements and AQL sampling plans.
  • Ability to perform mathematical calculations accurately.
  • Legible handwriting for documentation purposes.
  • Basic proficiency with personal computers and business software (e.g., MS Office).
  • Highly developed oral and written communication skills.

Nice-to-haves

  • Lean Six Sigma or process improvement training.
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