Manager, Analytical Laboratory

This position oversees all Quality Control Analytical Laboratory 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 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 documents.

Primary Duties & Responsibilities:

• Manage and develop a team of Analytical Chemists, Laboratory Technicians                         
• Ensure all inspections, testing and OTC documentation including SOP’s are current and properly stored according to current systems.                    
• Perform analytical methods transfer to the Quality Control laboratory, help and support the R&D analytical laboratory staff in method validation                                                      
• Perform OOS investigations and maintains records according to GMP guidelines.  Maintains retains of inspection samples.
• Responsible for the maintenance and calibration of all analytical instruments and maintaining required levels of laboratory supply inventory                                  
• Recruit, train and evaluate performance of staff.                                                                              
• Manage team schedules to support the plant operation across all shifts (first, second and third if needed)                                                                                                                               
• Stay abreast of industry standards and advancements.   Recommend innovative ways of improving 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 cross functional departments including planning, production, purchasing, finance, warehouse and human resources.
• Actively participate in the resolution of quality issues by working with cross functional team members such as packaging, production, manufacturing and technical groups.
• Support new product development efforts and identify and justify enhancements for improved throughput, cost, and/or quality.

Financial Accountability

Manage business while adhering to approved Analytical laboratory 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.

Trust 8 Competencies