Job Opening: Director of R&D and Quality

We have a direct hire opening for a Director of R & D and QA in Prescott at a company that specializes in skincare and bath products. This is a 1st shift opening!

In this role, oversee the R&D and QA departments involved in the development of a diverse range of Cosmetic, Household, and Over-The-Counter (OTC) products.

You will manage the scale-up of production from pilot batches to full-scale manufacturing and will ensure that the quality of product formulations is maintained during the scale-up process.

Additionally, you will ensure that new technologies and processes developed are smoothly integrated into production.  

Direct Hire Opportunity – Be on our client’s payroll from Day 1!

Salary and Shift Information:

• Salary: $100k/a year with a target bonus of 15% of the annual salary 
• This is a 1st shift opening

Job Duties of the Director of R & D and QA:

• Provide technical expertise to the QA, QC, and R & D departments to ensure they have the necessary knowledge to complete their tasks
• Ensure that manufacturing instructions and batch records are clear and accurate for scaling up production from pilot batches to full-scale manufacturing
• Act as a Subject matter expert for scaling up production and ensuring quality; ensure the transition from small-scale batches to full-scale production meets quality standards
• Handle all necessary applications, permits, and forms to maintain compliance with state, local, and federal regulations regarding chemical use at the site
• Ensure systems, processes, procedures, and policies are fully compliant to regulations, standards, directives, policies, and best practices
• Manage 3rd party testing of products to ensure they meet FDA requirements for over-the-counter products, including approving protocols, reviewing/approving reports, and keeping paper and electronic records of testing documents
• Uphold lab housekeeping practices to ensure lab cleanliness meets or exceeds FDA, NOP, NPA, and cGMP standards for compliance
• Oversee the company’s quality management system to ensure operations comply with all federal and international standards/regulations; ensure continuous improvement
• Review quality metrics and interpret data related to process validations, process controls, and continuous process improvements; make adjustments to processes as necessary to enhance quality
• Assist the purchasing in identifying and qualifying suppliers and vendors that meet the company’s quality standards.
• Oversee quality compliance programs that are in place to address and resolve quality issues effectively
• Lead problem-solving processes, including conducting root cause analyses and implementing corrective actions for quality issues
• Lead all audit preparation activities and participate in audits conducted by regulatory authorities to ensure compliance with all relevant standards
• Manage both internal and external audits focused on Good Manufacturing Practices and regulatory compliance
• Oversee investigations into issues like nonconforming products, customer complaints, lab specifications that are out of spec, corrective and preventative actions, and recall programs
• Ensure all investigations are completed in a timely manner and implement a system for monitoring and reporting any adverse events.
• Offer guidance, interpretation, and training regarding the implementation of regulations, guidelines, and company procedures, and policies to staff; ensure they understand and comply with these standards
• Develop and enforce quality control measures across all operational areas, including quality systems, facilities, equipment, materials management, production, packaging, and labeling
• Review and resolve any issues with batch records to ensure production needs are met and ensure documentation is accurate and up to date
• Examine and interpret the results of stability testing to assesses how the quality of a product changes over time
• Lead a cross-functional risk management program to identify potential risks; provide updates to management for review
• Develop and measure metrics (KPIs) to drive continuous improvement in quality
• Oversee company-wide training programs to ensure staff are up-to-date on processes, regulations, and standards
• Manage the document control system to keep records accurate and accessible