Supervisor, Quality Operations

PCI Pharma Services•Rockford, IL

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 daily quality activities, supports packaging production inspections, and helps ensure quality records and customer requirements are met. The Supervisor trains and develops staff, improves departmental work practices, supports internal audits and investigations, and oversees pest control and environmental monitoring programs. The position may require overtime and weekend work and carries out the essential functions of the Quality Operations Manager in their absence. The role is based in the Assembly department.

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 fluently and accurately for professional needs.
  • High reasoning ability to solve practical problems and handle varied situations with limited standardization.
  • Ability to interpret instructions provided in various forms.
  • High standard of report writing.

Nice To Haves

  • Ability to present information effectively to various people as required by the job.
  • Ability to work independently and/or as part of a team.
  • Willingness to make decisions.
  • Excellent time-management skills.

Responsibilities

  • Coordinate the daily activities of QA Auditors.
  • Assist with the daily activities of Production Inspection personnel for packaging.
  • Implement inspection criteria and testing.
  • Study and standardize departmental work practices to improve quality and efficiency.
  • Help resolve quality-related issues with other departments and customers.
  • Motivate, develop, and provide ongoing training to subordinates on work instructions, cGMPs, SOPs, customer requirements, and related topics.
  • 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 the testing equipment and supplies needed by the department.
  • May assist with investigations and write reports, memos, or letters.
  • Carry out the essential functions of the Quality Operations Manager in their absence.
  • Adhere to PCI, cGMP, and GCP policies, procedures, and rules.
  • Perform Quality Health Check assessments to determine whether processes and daily activities are performed according to procedures.
  • Perform other duties as assigned by a Manager or Supervisor.

Benefits

  • Annual performance bonus eligibility.
  • Paid time off.
  • Health insurance coverage, including dental and vision.
  • Flexible spending account.
  • 401(k).
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