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Finished Product Quality Assurance Supervisor

2 months ago

Verona, Wisconsin, United States Randstad Life Sciences US Full time

Position Title: Quality Control Supervisor – Finished Product

Employment Type: Direct Hire

Salary Range: $75,000 to $90,000

Work Schedule: 1st shift, 8:00 AM to 4:30 PM, Monday through Friday

Randstad Life Sciences US is seeking a Quality Control Supervisor with experience in a regulated pharmaceutical or food production environment. The ideal candidate will possess proven supervisory skills, leading a team of six direct reports and assisting in the development of performance evaluations. Effective communication is essential, as this role involves collaboration with various levels of management.

Role Overview:

The Quality Control Supervisor for Finished Products will primarily support the Formulations, Supply Chain, Quality Assurance, and Production Departments by organizing the analysis of pharmaceutical, dietary supplement, or food samples submitted to the QC laboratory. This role ensures that samples are analyzed in accordance with internal protocols, specifications, and established analytical methods, as well as compendia monographs and client-specific procedures. The supervisor will mainly focus on commercial production and stability testing.

The QC Supervisor is expected to have a comprehensive understanding of USP, EP, ICH, and FDA regulations pertaining to finished products, including necessary validations. This position will lead laboratory investigations, such as quality and out-of-specification inquiries, as required.

Key Responsibilities:

  • Mentor, train, and oversee the Finished Product team while providing support to the Raw Material team as necessary.
  • Assist QC Management in prioritizing workloads and provide updates to internal and external stakeholders.
  • Coordinate analytical activities related to finished products with direct reports, management, clients, contract laboratories, and vendors.
  • Draft, review, and approve standard operating procedures (SOPs), analytical methods, material specifications, and investigation reports.
  • Develop and implement protocols and summary reports for routine stability studies, method validations, and method transfers.
  • Create Certificates of Analysis (CoA) for in-process and commercial finished products as needed.
  • Review Annual Drug Product Review (ADPR) documents for accuracy.
  • Oversee testing procedures involving dissolution, HPLC, GC, UV analysis, and various wet chemistry techniques.
  • Support Analytical Chemists and Scientists with method troubleshooting and compliance inquiries.
  • Participate in client and regulatory audits, as well as contract laboratory qualification audits.
  • Stay informed of evolving regulatory and industry standards (e.g., USP, FCC, EU).
  • Generate and analyze QC metrics.
  • Review laboratory notebooks and forms as necessary.
  • Maintain a clean and organized QC laboratory environment.
  • Conduct annual performance evaluations and regular meetings with direct reports.
  • Adhere to all client cGMP and safety protocols.
  • Ensure familiarity with Halal and/or Kosher requirements as applicable.
  • Perform additional duties as assigned.

Qualifications:

  • Minimum of 5 years of supervisory experience in a cGMP pharmaceutical or similar environment; an advanced degree may substitute for experience.
  • Extensive knowledge of QC analytical equipment (e.g., HPLC, GC) and method development.
  • Demonstrated leadership abilities to effectively train and motivate QC personnel.
  • Strong time management skills to complete tasks efficiently with minimal supervision.
  • Ability to establish and maintain effective working relationships with team members, colleagues, vendors, and clients.

Benefits Offered:

  • Comprehensive Medical, Dental, Vision, Life, AD&D, and Disability Insurance
  • 401K Retirement Plan
  • Tuition Reimbursement Program
  • Paid Time Off - Accrue up to 17 days of PTO within the first year