Near DFW Airport
Current Quality Management experience to include CAPA and root cause analysis at a food, pharmaceutical, cosmetics, or related manufacturer required. 1st shift.
Position Summary
Responsible for the day-to-day functions of the Notice of Event (NOE) system within a cosmetic/ OTC drug manufacturing facility. Responsible for documenting, reviewing, and facilitating root cause analysis investigations associated with the production of OTC drug products. This role will assist in the development, 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 development and execution of NOEs and CAPAs against a timeline; will train other teams on NOE documentation and root cause analysis practices; and must have a good knowledge of general manufacturing processes.
The ideal candidate will demonstrate technical leadership and provide strong support; develop technical solutions to complex problems that require innovation and creativity; lead projects outside of usual scope; regularly initiate innovative procedures and make strategic recommendations to improve processes.
Responsibilities and Essential Duties
- Act as administrator of the NOE and CAPA systems to ensure a timely and compliant closure.
- Conduct or help facilitate investigations of undesirable trends in production process performance and unplanned events by performing root cause analysis and developing/implementing effective CAPAs.
- Improves existing Quality Systems and develops new quality processes through implementing associated procedures and other documentation.
- Provides technical support for improvement initiatives of product and process capability based on company and customer metrics.
- Review, trend, and report on each drug product annually (Annual Product Review).
- Assemble, maintain, and report Quality metrics.
- Review, develop, revise, and approve quality-related documents as needed.
- Support internal and external compliance audits and defend their work to regulatory agencies.
Technical Skills Required
- Must possess strong technical skills. Certification by ASQ as a CQE, CRE, or SSGB is strongly preferred.
- Must have exceptional knowledge of FDA regulations and Good Manufacturing Practice (GMP) regulations, as well as excellent decision-making skills in order to make risk assessments and determine the most efficient utilization of resources to accomplish departmental objectives.
- Excellent communication (oral and written), change management, and leadership skills are required in order to interface with all levels of management and to coach, train, and motivate technical staff.
- Must possess excellent project management skills in order 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 and leadership skills in order to effectively meet objectives.
- Computer skills to include proficiency with Microsoft Office software.
Experience Required
- Bachelor’s degree or equivalent experience.
- Minimum 2 years 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.