Job Location: Oxford, NC
The Quality Systems & Compliance Specialist will assist the Manager of QA S&C and will interface with Quality Control, Quality Assurance, Manufacturing, Supply Chain and R&D to drive Continuous Improvement to our processes, systems, and products.
The Specialist will rely on Quality Standards & Policies for the Revlon Oxford Manufacturing Facility, located in North Carolina.
The QA S & C Specialist will audit and trend QS and make recommendations on implementing, coordinating, and improving the site quality system in accordance with applicable guidance, standards, and regulations.
Basic Function
- Trends and confirms implementation caliber for the Site’s Quality Systems, i.e. change control, Nonformance process, Root cause and CAPA review, and supports the Site Management Reviews as established and maintained. Supports the performance of the Quality System in conjunction with the Manager of Quality Compliance.
- Monitors Quality System trends and brings those systems in need of corrective action to upper management’s attention. Assures implementation of Corrective action as required, confirms effectiveness, and maintains documentation accordingly.
- Reviews procedures and regulations in alignment with current facility practices and recommends follow up continuous improvement training as necessary.
- Reviews Metrics for appropriateness / applicable to regulatory guidance and practices. Aligns those KPI/Metrics with daily and weekly activities confirming the metrics are supportive of Quality and R&D policies, procedures, and goals.
- Supports the Manager for conducting and reporting on Internal Audits of the local factory and desk audits of alternate Revlon factories to fulfill Self-Inspection. Further, to provide and track improvement and success in audit responses as recommendations for improvement are implemented. Track the Internal Audit schedule and working with QC and Operations provide an internal audit response / tracker to identify status of improvement. i.e., track improvement plans and identify any lagging activity.
- Support equipment qualification activities as needed within document review / tracking. Knowledge of Quality standards, FDA Guidance, QC Testing methodologies in support of equipment qualification activities.
- Provide support for external audits of Oxford, NC.
- Responsible in understanding compliance in accordance with regulations and standards such as but not limited to 21CFR 210, 21CFR211, 21CFR820, ISO 27716, ISO 13485
- Responsible for review and knowledge of Revlon Global Procedures written to support the Global Quality Assurance Program. Industry specific FDA; Canada; Europe; Global markets.
- Provide problem solving skills and expertise to drive solutions.
- Assist with execution of cGMP Training as required.
- Able to handle multiple projects simultaneously.
Required Competencies, Skills, Experience
- 3-5 years industry experience
- Proficient in the computer applications of Office suite: Word & Excel; Experience with Sharepoint systems; SAP general knowledge.
- Hands-on knowledge of laboratory practices, microbiology, analytical exposure, quality control and quality assurance best practices, etc. Must have experience with GMP Manufacturing, Quality and Compliance: GMP/GLP or GXP and CFR requirements
- Good written and oral communication skills to effectively reach all levels of the organization, including the ability to brainstorm solutions, monitor and provide recommendations for improvement.
- Must be able to prepare and convey data analysis to manager and others within a group with clarity and accuracy.
- .Self-directed, complete routine tasks independently and be confident in making decisions, in consult with management.
Education
- B.S. or B.A. in the Sciences: Applied Science, Biology, Chemistry, Engineering etc.
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