Engineer, Quality Assurance

ZipRecruiter; Oxford; On-site; USD 75,000 - 85,000; Full time

Job description

Job 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 requests 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 systems.
• 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.
• 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 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, supplemental life insurances, flexible spending accounts, critical illness insurance, group legal, 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.