Quality Engineer III, Pharma
Location
Newark, DE | United States
Job description
Requisition ID : 492466
Job Description
The Quality Engineer is focused on implementing quality engineering tools and skills to monitor and guarantee quality. This role will focus on day-to-day Quality support of production processes, conducting investigations, and developing and implementing improvements to existing processes and products as assigned to meet quality and regulatory requirements. The Quality Engineer schedules, executes, & communicates all items regarding quality issues, complaints, validations & other projects to Quality Management, and/or other interested parties. The role serves as a strong advocate for product, process, and system quality at all stages of product realization. Support customer complaint data acquisition, root cause analysis, corrective action, and complaint handling. Also, perform all duties associated with the auditing and documentation of compliance-related items against GMP and ISO standards.
In order to succeed in this role the Quality Engineer should:
- Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
- Lead or participate in Root Cause Failure Analysis (RCFA) about deviations, incident investigations, complaints, etc.
- Write, review, and approve product/process deviations or reprocess/rework documentation.
- Work independently and with project teams to develop deliverables including quality plans, manufacturing & inspection documentation, test methods, and any other necessary quality records.
- Support quality assurance improvement activities by evaluating products, processes, or materials to develop control or improvement strategies intended to improve compliance, product quality, and/or the customer’s experience.
- Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.
- Maintain information and statistics on the program’s quality performance.
- Write operating procedures.
- Complete auditor certification and perform internal ISO and quality systems audits by ISO standards including recommending ways to resolve any issues identified by the audits.
- Recommends and performs appropriate quality controls, process testing, and corrective action as needed to ensure product and process integrity.
- Troubleshoot production quality issues.
- Monitor and track product quality data, identify existing trends, drive quality improvement efforts, offer suggested conclusions, and recommend follow-up action.
- Analyze, generate, and report findings from Cp/Cpk studies and other analytical/statistical methods.
- Provides ongoing status follow-up with internal and external customers to support projects and programs.
- Provides ongoing assistance to engineering by establishing and refining quality plans and systems.
- Assumes responsibility for various assigned projects designed to improve product quality, reduce costs, and/or validate facility products or processes, including the development and implementation of any new or required inspection methods.
- Provides a "Customer Service" attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
- Evaluate process changes, new processes, equipment, etc., to determine requirements for measurement accuracy for plant instruments and equipment.
- Support the plant's safety, health & wellness environmental, and industrial hygiene programs.
- Ensure all changes, new processes and equipment have been reviewed and comply with current Good Manufacturing Procedures (cGMP), ISO, and other quality and regulatory standards.
Job Requirements
- B.S. degree in Chemistry, Engineering(Chemical, Mechanical, or Industrial), or Business.
- 3-10 years of experience in manufacturing operations or equivalent experience.
- Interpersonal skills for working in teams across functions.
- Basic project and time management skills.
- Familiarity with all applicable regulatory requirements, risk assessment tools (e.g., FMEA, HACCP, etc...), and certification standards (quality, environment, sustainability, GMPs).
- Solid Knowledge of the Pharma/Flavor/Food/Fragrance/Cosmetic industry.
- Six Sigma Greenbelt/Black belt.
- ASQ Quality Engineer Certification.
- Excellent written and oral communication skills.
- Ability to work with cross-functional teams in a diverse work environment.
- Exceptional analytical skills with demonstrated ability to consistently solve problems decisively and efficiently.
- Knowledge of statistical analysis to be used for process improvement.
- Knowledge of root cause analysis methodologies.
- Knowledge of quality control procedures, processing equipment, plant utilities, or equivalent experience at a manufacturing plant.
Preferred Knowledge, Skills, and Abilities:
- Knowledge/experience of pharmaceutical or food additive plants.
- ISO 9001:2015 Internal Auditor.
- HACCP Certification.
We are a global leader in taste, scent and nutrition, offering our customers a broader range of natural solutions and accelerating our growth strategy. At IFF, we believe that your uniqueness unleashes our potential. We value the diverse mosaic of the ethnicity, national origin, race, age, sex or veteran status. We strive for an inclusive workplace that allows each of our colleagues to bring their authentic self to work regardless of their religion, gender identity & expression, sexual orientation, or disability.
Visit IFF.com/careers/workplace-diversity-and-inclusion to learn more.
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