Sr Quality Engineer

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

ESSENTIAL FUNCTIONS:

• Write, review and approve Exceptions, OOSs, CAPAs, Customer Complaints and Change Controls in a computerized system
• Provide direct support for regulatory inspections andcustomer audits
• Ensure appropriate responses to internal, corporate, customer and regulatory audits/inspections
• Provide for and ensures appropriate support is provided for regulatory and customer inquiries
• Develop systems for ensuring cGMP compliance of manufacturing documentation systems, quality of documentation, and remediation of issues
• Report and present trends to management groups during scheduled review periods
• Lead and participate in Root Cause Analysis and Process Improvement Teams
• Regularly use communication skills to exchange information, including technical, with other departments
• Follow all internal and basic cGMP guidelines for pharmaceutical operations
• Adhere to all safety rules and maintain 100% completion of all required training

MINIMUM REQUIREMENTS:

Education:

Bachelor of Science degree in Chemistry, Chemical Engineering, or related science is required; CQE Certification preferred

Experience:

• Minimum of5 -8 years of experience in Quality Assurance/Quality Control in a pharmaceutical manufacturing environment
• 2+ years of experience managing investigations, OOS, CAPAs and Change Controls
• Proven project management history
• Demonstrated expertise in root cause analysis tools

Preferred Skills/Qualifications:

• Excellent oral/written communication and leadership skills
• Ability to effectively communicate to customers, internal and external
• Understanding of basic statistical principles and regulatory expectations
• Proficient in Minitab, BPCS and TrackWise applications
• Knowledge of cGMP's for APIsincluding ICH Q7, CFR 210 and 211
• Knowledge of Quality Systems
• Bias toward change, management of change, and achievement of results
• Ability to quickly identify, communicate and/or resolve issues
• Ability to build relationships with partners
• Advanced Microsoft Office and computer skills

COMPETENCIES:

Decision Quality, Managing Diversity, Learning on the Fly, Managerial Courage, Organizing, Priority Setting, Problem Solving, Drive for Results, Presentation Skills

RELATIONSHIP WITH OTHERS:

Daily interaction with Manufacturing personnel, Quality Engineers, Quality Control Labs, and Quality Management members to provide guidance to resolve issues

WORKING CONDITIONS:

• 10% Laboratory exposure to plant products, solvents, reagents, some of which are hazardous or potent compounds.
• 10% Manufacturing environment exposure including temperature, noise, chemical or potent compound exposure.
• 80% Office environment which requires sitting for long periods of time and computer use.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.