In - process Quality Engineer

Quality Engineer

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

The Quality Engineer performs a variety of quality-related functions with the intent of providing Quality guidance and support to manufacturing operations at the St. Louis Plant. The scope of the position includes responsibility in OOS investigations, CAPAs, Exceptions, Change Controls, and Customer Complaints. Serves a technical resource in the Quality function in partnering with Manufacturing, Supply Chain, and other Quality groups.

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 required.

EEO Statement

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.