Quality Assurance Team Leader

2 weeks ago

Pleasant Prairie, Wisconsin, United States Concept Laboratories Full time
Job Overview

Position Title: Quality Assurance Supervisor

Department: Quality Assurance

Reports to: Director of Quality

Position Summary:

The Quality Assurance Supervisor plays a crucial role in the effective execution of the company's quality policies and procedures. This position is vital for maintaining high standards in the quality of manufactured products. The supervisor will collaborate closely with other department leaders to ensure product quality, troubleshoot issues, enhance productivity, and adhere to regulatory standards.

Key Responsibilities:

  • Manage the daily operations of the quality assurance department.
  • Conduct timely and constructive performance assessments of team members.
  • Supervise quality assurance technicians and auditors to ensure compliance with cGMP and quality policies.
  • Perform analytical testing using various instruments (e.g., GC, HPLC, FT-IR, UV-Vis).
  • Review production batch records and related documents for compliance and integrity.
  • Coordinate testing results for finished products, raw materials, and packaging components.
  • Oversee the management of products on hold, including their status and resolution.
  • Maintain controlled documentation through a robust document control system.
  • Assist in the investigation of deviations and quality-related issues.
  • Conduct audits of raw materials and finished products to ensure compliance with specifications.
  • Monitor compliance with implemented quality programs (GMPs, ISO, etc.).
  • Collaborate with other departments to resolve quality-related concerns.
  • Provide recommendations for improvements in quality systems and processes.
  • Manage supply orders and departmental invoices.
  • Support internal audits and documentation collection.
  • Track training completions and maintain QA training records.
  • Adhere to safety policies and procedures.
  • Initiate investigations for non-conformance issues.
  • Compile performance metrics and data for management review.
  • Identify areas for operational improvement.
  • Support regulatory inspections of quality systems.
  • Perform additional administrative tasks as assigned by management.

Required Qualifications:

  • Strong verbal and written communication skills.
  • Proficiency in analytical chemistry and instrumentation.
  • Excellent problem-solving and mathematical skills.
  • Ability to collaborate effectively with team members.
  • Proficient in Microsoft Office Suite.
  • Knowledge of cGMP, FDA regulations, and ISO standards.
  • Exceptional organizational skills and attention to detail.
  • Strong time management abilities with a focus on meeting deadlines.
  • Demonstrated leadership and supervisory skills.
  • Capacity to prioritize and delegate tasks effectively.
  • Able to thrive in a fast-paced and dynamic environment.
  • Willingness to work flexible hours as needed.

Education and Experience:

A bachelor's degree in a scientific discipline (e.g., chemistry, biology) and a minimum of five years of experience in Quality Assurance, preferably in the cosmetics, biologics, medical device, or pharmaceutical sectors.

Physical Requirements:

Ability to sit for extended periods and work on a computer. Must be able to lift up to 15 pounds occasionally.

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