Quality Improvement Investigator I

Responsible for documenting, reviewing, and facilitating root cause analysis investigations associated with the production of cosmetic and OTC drug products. This role will assist in the improvement and implementation of the organizations Quality Systems under the direction of Quality Management; will work closely with Operations, R&I, Quality, and Commercialization team members in the execution of Notice of Events (NOE) and CAPAs against a timeline; will assist other teams with NOE documentation and root cause analysis; and have a good knowledge of general manufacturing processes.

The ideal candidate will provide support; assist in developing technical solutions to complex problems that require innovation and creativity; assist with projects outside of usual scope; regularly initiate innovative procedures to improve processes.

• Assist in facilitation of the NOE and CAPA systems to ensure a timely and compliant closure.
• Conduct or assist in the facilitation of investigations of undesirable trends in production process performance and unplanned events by performing root cause analysis and developing/implementing effective CAPAs.
• Improve existing Quality Systems and assist in the development of quality processes through implementing associated procedures and other documentation.
• Provide technical support for improvement initiatives of product and process capability based on company and customer metrics.
• Assemble, maintain, and report Quality metrics as required.
• Support internal and external compliance audits and defend their work to regulatory agencies.

• Must possess strong technical skills.
• Must have current knowledge of FDA regulations and Good Manufacturing Practice (GMP) regulations.
• Must be able to communicate clearly, orally and in writing, and exchange information accurately.
• Must possess excellent project management skills to coordinate multiple projects and adhere to tight timelines while working with people at all levels of the organization.
• Must be self-motivated and possess strong problem-solving and critical thinking skills.
• Must have excellent interpersonal skills to effectively meet objectives.
• Must possess proficient computer skills, including Microsoft Office software (Word, Excel, PowerPoint).

• High School degree or equivalent.
• Experience in root cause analysis and CAPA development/implementation.
• Experience in FMCG environment (Cosmetic, Food, or Pharmaceutical).
• Experience with requirements for Cosmetic and OTC products in line with cGMP and FDA CFR 21 Part 210/211 procedures, as well as knowledge of Safety and OSHA regulations.

• Must be able to climb stairs, stand for long periods of time and can bend.
• Move, transport, and position up to 25 pounds.
• Move about inside the production environment safely.