Supervisor, Quality Operations

PCI Pharma Services•Rockford, IL
•$62,960 - $70,830

About The Position

The Supervisor, Quality Operations determines and maintains quality standards in compliance with current Good Manufacturing Practices (cGMP), company Standard Operating Procedures (SOPs), and customer requirements. The role resolves quality deviations and issues and recommends solutions based on SOP and cGMP requirements. It coordinates QA Auditor activities, supports production inspection personnel, and helps ensure quality and customer requirements are met. The supervisor also develops and trains staff, oversees monitoring programs, and carries out the essential functions of the Quality Operations Manager when that manager is absent.

Requirements

  • Bachelor's degree in a related field and/or 1–5 years of related experience and/or training.
  • College-level mathematical skills.
  • Intermediate computer skills, including the ability to perform more complex computer tasks and knowledge of various computer programs.
  • Full professional proficiency in speaking, reading, and writing for professional needs.
  • High reasoning ability to solve practical problems and interpret varied instructions in situations with limited standardization.
  • High standard of report writing.

Nice To Haves

  • Ability to present information effectively to different audiences as required by the job.
  • Ability to work independently and as part of a team.
  • Willingness to make decisions.
  • Excellent time management skills.

Responsibilities

  • Coordinate the daily activities of QA Auditors.
  • Assist with daily activities of Production Inspection personnel for packaging.
  • Implement inspection criteria and testing studies, and standardize departmental work practices to improve quality and efficiency.
  • Help resolve quality-related issues with other departments and customers.
  • Motivate, develop, and provide continuous training through work instructions, cGMPs, SOPs, customer requirements, and personal instruction.
  • Review records for accuracy and compliance with established procedures.
  • Review daily paperwork to ensure customer requirements and quality standards have been met and maintained.
  • Promote continuity between shifts through cooperation and communication within the department and with other departments.
  • Assist with monthly internal audits and follow up on necessary corrective actions.
  • Oversee Pest Control and Environmental Monitoring Programs, including humidity, temperature, and MKT monitoring.
  • May disposition NMRs.
  • Recommend and participate in disciplinary activities involving subordinates.
  • Maintain testing equipment and departmental supplies.
  • May assist with investigations and write reports, memos, or letters.
  • Adhere to PCI, cGMP, and GCP policies, procedures, and rules.
  • Perform Quality Health Check assessments to determine whether processes and day-to-day activities follow procedures.
  • Carry out the essential functions of the Quality Operations Manager in that person's absence.
  • Perform other duties as assigned by the Manager or Supervisor.
  • Maintain attendance at work as an essential function of the position.

Benefits

  • Paid time off
  • Health insurance coverage
  • Dental insurance coverage
  • Vision insurance coverage
  • Flexible spending account
  • 401(k)
  • Annual performance bonus eligibility
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