Quality Assurance Chemist Team Leader

2 weeks ago

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

Position Title: Quality Control Chemist Supervisor

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 industry setting within a QA/QC framework. The ideal candidate will possess proven supervisory skills, managing a team of six direct reports, and will be responsible for developing performance evaluations for team members. Effective communication is essential as this role involves interaction with various leadership levels. Responsibilities include scheduling, reviewing daily metrics, and overseeing standard operating procedures (SOPs), methods, and specifications.

Role Overview:

The Quality Control Supervisor will primarily support the Formulations, Supply Chain, Quality Assurance, and Production Departments by coordinating the analysis of pharmaceutical, dietary supplement, or food samples received in the QC laboratory. This role ensures that samples are analyzed according to established procedures, specifications, and analytical methods, including compendia monographs and client protocols. The supervisor will focus on commercial production and stability testing, maintaining compliance with internal procedures and good laboratory practices.

The QC Supervisor is expected to have a comprehensive understanding of USP, EP, ICH, and FDA guidelines relevant to finished products, including necessary validations, and will lead laboratory investigations 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 providing updates internally and externally.
  • Coordinate all analytical activities with direct reports, management, clients, contract laboratories, and vendors.
  • Draft, review, and approve SOPs, analytical methods, material specifications, and investigations.
  • Implement protocols and summarize reports related to stability studies, method validations, and 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 involving dissolution, HPLC, GC, UV analysis, and various wet chemistry techniques.
  • Assist Analytical Chemists and Scientists with method troubleshooting and compliance.
  • Participate in client and regulatory audits, as well as contract lab qualification audits.
  • Stay informed of changing regulatory and industry standards.
  • Generate and review QC metrics and perform data reviews of laboratory documentation.
  • Maintain a clean and organized QC laboratory environment.
  • Conduct annual performance reviews and regular meetings with direct reports.
  • Adhere to all client cGMP and safety protocols.
  • Be familiar with Halal and/or Kosher requirements as applicable.
  • Other duties as assigned.

Qualifications:

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

Benefits:

  • 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

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