Manager, Analytical Laboratory

1 month ago

White River Junction, Vermont, United States Shiseido Full time

Job Summary

The Manager, Analytical Laboratory position oversees all QC Analytical lab and micro labs policies, procedures, and practices that establish systems compliant with GMP regulations and expectations of domestic and International regulatory agencies. Responsible for the coordination of workflow in Analytical Laboratory and micro lab including the minimization of sample cycle time. Ensure the labs maintain conformance to established quality expectations, GMP, FDA and OSHA compliance. Controls the quality of OTC products and maintains the records and the documents.

Primary Duties & Responsibilities:

  • Supervise / Manage the work of Analytical Chemists, Lab Technicians and Microbiologist in the QC lab.
  • Ensure all inspections, testing and OTC documentation, including SOPs are current and systematically stored.
  • Perform analytical methods transfer to the QC lab, help and support the R&D analytical lab in method validation
  • Perform OOS investigations and maintain records according to GMP guidelines. Maintain retains of inspection samples.
  • Maintain analytical instruments and lab supplies inventory
  • Recruit, train and evaluate performance of QC lab staff.
  • Manage the staff time and schedule to support the plant schedule during all shifts (first, second and third if needed)
  • Search and recommend different ways of doing the lab work or the flow of the material in the lab such as automation to improve efficiency, cost and competitiveness in the market.

Working Relationships/Key Stakeholders:

  • Solid and Cooperative working relationships with planning, production, purchasing, accounting, warehousing, and human resources departments.
  • Actively participate in the resolution of quality issues by working with cross functional team members such as packaging, production, manufacturing and technical groups.
  • Assist with new product development and identify and justify enhancements for improved throughput, cost, and/or quality.

Financial Accountability

  • Analytical and micro lab budget

Qualifications & Competencies:

  • Bachelor's degree in chemistry or related field is required.
  • 5- 7 years of experience in Quality department (OTC Cosmetics industry) with demonstrated ability to identify, define and implement quality systems.
  • Solid knowledge of GMP systems as applied to ISO 22716 and OTC Cosmetics and drug products.
  • Knowledge and understanding of domestic & international regulations (FDA, TGA, HPB and ICH), guidelines and practices for cosmetics and OTC products.
  • Strong knowledge of analytical and microbiological methods and practices
  • Leadership Skill - Strong drive to deliver business goals and identifies new opportunities. Ensures long term success by creating objectives and committing resources to sustain the future of the organization.
  • Management Skills - Demonstrated ability to set and communicate clear standards and expectations. Develops and supports an open environment where challenge is viewed positively. Aware of own impact and what drives and motivates others. Provides coaching and feedback to help employees perform at their best.
  • Language Skills- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
  • Reasoning Ability- Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
  • Computer Skills - Strong knowledge of Microsoft Office is required
  • Certificates, Licenses, Registrations - ASQ GMP certification, Quality Manager certification, and Quality auditor certification is a plus.

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