Engineer, Quality Assurance

POSITION OVERVIEW
• This role will drive culture change in the organization to that of a harmonized, consistent Quality Unit and expectation.
• No Direct reports.

MAJOR DUTIES
People
• Develop excellent working relationships with Oxford peers, R&D, Package Development, Package Engineer, Regulatory, Shop Floor and management.
• Mentor and coach team as well as all cross-functional colleagues on process-based root cause problem solving.
Culture
• Drive culture change, to one that is data-driven, fact-based, and quality-oriented, without sacrificing plant capacities and output.
Quality
• Support New Product Development and Existing Product innovation/launches. (Operations, R&D, QC, etc.) and follow up on plans.
• Prior experience operating within quality systems as either a user or owner to review or approve GMP documents (change controls, deviations, CAPAs).
• Assess changes via NPD, change controls, deviations, etc. for impact on validated systems (Equipment, Cleaning, Process, etc.).
• Assist in defining, testing, and implementing comprehensive guidelines and procedures for all manufactured products to ensure products and processes meet all regulatory and customer requirements.
• Review and approve Quality Investigations, Nonconformance(s) and Quality Complaint(s) assigned to the Oxford location.
• Identify and lead continuous improvement opportunities within quality systems and other areas as appropriate.
Delivery/Innovation
• New Product Development (NPD) is the driver of our industry’s success. Do what it takes to achieve Ship-to-Trade (STT) dates without sacrificing cGMP compliance, Safety of the end user, and brand Quality expectations.
Cost
• Support directly all assigned cost reduction initiatives. Be aware of the business impact that quality has on cost reduction and suggest projects to achieve plant goals.
Key Partners
• Will need to build solid relationships with all functions of the organization, in particular Global QA, plant Quality Control (QC), Regulatory Affairs (RA), R&D Development and Services, Packaging Development and Engineering, Supply Chain, Revlon-owned plant and Production.
• Other duties as assigned.
• Minimal to no travel required. 

EXPERIENCE and EDUCATION/CERTIFICATIONS
• Minimum of 4 years of relevant experience within the consumer personal care industry and/or pharmaceutical industry.
• Bachelor’s degree of science degree preferred, such as Engineering, Microbiology, Chemistry. Associate’s degree with 5 years of experience with a proven track record of industry experience will be considered.
• Experience working in a cGMP environment and good understanding of regulations and industry guidance including but not limited to FDA, Health Canada, EMA, and ICH.

KNOWLEDGE, SKILLS & ABILITIES
• Engaging and motivational personality that enjoys being a part of the team, so that strong, tight-knit cross-functional teams are built and the culture is changed as needed to drive business growth. Communication and relationship-building is a critical skill for this role.
• Experience leading or at least participating in strong culture change using influential leadership skills rather than authoritative practices. People should see the value in what is being driven for change and want to follow.
• Experience leading or participating in auditing activities for cGMP compliance.
• Enjoys learning and development and considers self an emerging Subject Matter expert (SME) on the FDA regulations governing OTC and non-OTC products; prefer to also have experience with ISO 9001, ISO 22716, European regulations, and ICH guidelines.
• Ability to manage time and workload so that the goals and objectives for each role are met, using appropriate prioritization strategies.
• Proficiency in standard business software (Word, Excel, Outlook, PowerPoint)
• Excellent oral and written skills coupled with the ability to succeed in a teamwork-oriented atmosphere.
• General experience with SAP or other ERP systems.

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