In-Process Quality Engineer

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

ESSENTIAL FUNCTIONS:

• Review and approve Exception and OOS investigations, CAPAs, Change Controls, and Customer Complaints in TrackWise system
• Generate data for Annual Product Reviews
• Organize and document Material Review Boards for product disposition
• Review release packets prior to final release of Finished Goods
• Review and approve Validation Protocols
• Participate in Root Cause Analysis and Process Improvement teams
• Participate in Internal Audit Program
• Support Regulatory filings and updates as applicable
• Perform GMP walkthroughs with manufacturing on a routine basis
• Provide direct support for regulatory inspections and customer audits
• Follow all internal and basic cGMP guidelines for pharmaceutical operations
• Adhere to all safety rules and maintain 100% completion of all safety required training
• Maintain 100% on time Compliance Wire training

MINIMUM REQUIREMENTS:

Education:

BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies

Experience:

• Minimum 3-5 years of experience in Quality Assurance in a pharmaceutical manufacturing environment
• Experience with quality metrics, manufacturing investigations and product release

Preferred Skills/Qualifications:

• Excellent verbal and written communication skills
• Knowledge of cGMPs for APIs including ICH Q7, CFR 210 and 211
• Knowledge of Quality Systems
• Manufacturing or QC experience
• Understanding of basic statistical principles and regulatory expectations
• Ability to quickly identify, communicate and/or resolve issues
• Ability to understand complex master processes
• Ability to build and lead effective teams
• Ability to build relationships with partners

COMPETENCIES:

Dealing with Ambiguity, Conflict Management, Decision Quality, Peer Relationship, Priority Setting, Customer Focus, Directing Others, Time Management, Drive for Results

ORGANIZATIONAL RELATIONSHIP/SCOPE:

Daily interaction with Manufacturing personnel, Quality Engineers, Quality Control Labs, Focus Factory Managers, 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 require