Job Information
Revlon Engineer, Quality Assurance in Oxford, North Carolina
Description
Overview: * *
This role will drive culture change in the organization to that of a harmonized, consistent Quality Unit and expectation.
No Direct reports.
People
Develop excellent working relationships with both Oxford peers 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).
Assesses the impact of deviations, CAPAs, and associated change request on the validation status of equipment and/or systems.
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.
Lead, support, 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.
Establish and perform carryover limit calculations and determine appropriate carryover limits with documented rationale. (As applicable)
Support cleaning process development activities for CIP and COP, manual and automated processes.
Prepare detailed plans for coordination and execution of validation activities with various stakeholders (Operations, R&D, QC, etc.) and follow up on validation plans.
Author Validation Protocols and Reports. (Cleaning, Process, Systems, etc.)
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, and Revlon-owned plant Production
Other duties as assigned.
Minimal to no travel required
Experience:
Minimum of 4 years of relevant experience within the consumer personal care industry and/or pharmaceutical industry.
Bachelor of Science degree, such as Engineering, Microbiology, Chemistry or Associate of Science degree with 5 years of experience.
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.
Required Knowledge & Skills
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
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.
Demonstrated, hands-on experience with cleaning validation activities
General experience with SAP or other ERP system
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 critical as needed to drive business growth. Communication and relationship-building is a critical skill for this role.
Experience leading or participating in auditing activities for cGMP compliance.
The base pay range for this position is $75,000 and $85,000/year; however base pay offered may vary depending on skills, experience, job-related knowledge, and geographic location. Certain positions may also be eligible for short-term incentives as part of total compensation.
Employees (and their families) are eligible for medical, dental, and vision benefits. Employees are covered by the company-paid basic life insurance policy and company-paid short-term disability insurance (the benefit commences upon hire and allows for a portion of base salary for up to 26 weeks if you are disabled). Other benefits offered to employees include but are not limited to the following: long-term disability, supplemental life insurances, flexible spending accounts, critical illness insurance, group legal, identity theft protection, etc. Employees are also able to enroll in our 401k Retirement Savings Plan.
Employees will also receive 3 weeks of vacation, pro-rated based on date of hire for the 1st year of employment and twelve paid holidays throughout the calendar year. Vacation will depend on role.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)