Quality Engineer II

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

Summary of Position

The Quality Engineer performs a variety of quality-related functions with the intent of providing Quality support to manufacturing operations at the Fenton Manufacturing Plant. This will include new manufacturing processes that are transferred to the site. The scope of the position includes manufacturing batch record review, manufacturing and quality investigations, CAPA's, change controls. Also, provides support to the Sr. Validation Engineer with the creation, review and/or execution of qualification and validation activities for equipment, utilities, and manufacturing processes.

Job Results & Essential Functions

• Provides technical assistance during investigations of process/product issues. Supports validation deviations of process/product or equipment.
• Executes validations as needed, including assisting in product sampling, auditing and technical review functions as defined in study protocols.
• Assist with developing and executing utility and equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities supporting these operations.
• Assist with writing summary reports (close out report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies.
• Assist with development and review of cleaning validation protocols.
• Interacts with and coordinates compliance efforts with other departments including, but not limited to: Operations, Engineering, QA, QC laboratories and Tech Services to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed.
• Execute Line Clearances
• Identify exceptions and report exceptions
• Perform batch record review and accountability
• Create and/or revise Quality related SOPs
• Participate in Internal Audit Program
• Initiate and/or approve exceptions, change controls, and CAPAs in the Trackwise module.
• Participating in Root Cause Analysis teams
• Follow all internal and basic cGMP guidelines for pharmaceutical operations.
• Perform other duties as assigned
  

Key Competencies

• Building Collaborative Relationships: Shows an interest in what others have to say, acknowledges their perspectives and ideas; recognizes the business concerns and perspectives of others; takes time to get to know coworkers, to build rapport and establish a common bond; tries to build relationships with people whose assistance, cooperation and support may be needed; provides assistance, information, and support to others to build a basis for future reciprocity.
• Analytical: Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, mathematics, or other problem-solving tools in data analysis or in generating solutions; logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action; goes beyond analyzing factual information to develop a conceptual understanding of the meaning of a range of information; integrates diverse themes and lines of reasoning to create new insights or levels of understanding for the issue at hand; thinks in terms of generalized models rather than concrete details.
• Perseverance: Pursues everything with energy, drive, and a need to finish; seldom gives up before finishing, especially in the face of resistance or setbacks.
• Written Communications: Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect.

Minimum Requirements

Education: Bachelor's degree in chemistry, biology, engineering discipline or technical field related to pharmaceutical manufacturing is preferred. Equivalent experience in Quality Validation and quality functions will be considered.

Experience: Minimum of 3-5 years experience in Quality Assurance and/or previous experience in process, equipment qualification, cleaning validation and/or packaging validation experience in pharmaceutical manufacturing / packaging environment.

Preferred Skills/Competencies:

• Experience working with validation to facilitate project deliverables.
• Knowledge of FDA regulated drug validation requirements including knowledge of cGMP regulations in parts 201 and 2011, and FDA 21 CFR Part 11.
• Strong technical and mathematical aptitude.
• Knowledge of Quality Systems
• Knowledge of GMP's for Dosage Products
• Good verbal and written communication skills
• Strong computer literacy-MS office products, statistical analysis (Minitab) and database usage.

Physical Demands/Work Environment

80% office environment which includes sitting for long periods of time and computer use.

Less than 10% manufacturing environment exposure including temperature, noise, chemical or potent compound exposure.

Less than 10% of laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds.

Reporting/Organizational Relationships

Directly Reports to: Plant Quality Manager

NOTE: This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees may be required to follow other job-related instructions and to perform other job-related duties as requested, subject to all applicable state and federal laws. Certain job functions described herein may be subject to possible modification in accordance with applicable state and federal laws.