Sr In-Process Quality Eng

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

SUMMARY OF POSITION:

The Senior 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, supplier quality and validation.

ESSENTIAL FUNCTIONS:

Execute batch record review and document deficiencies
Identify exceptions and report exceptions
Resolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material release
Execute line clearances
Perform batch record accountability
Create and/or revise Quality related SOPs
Review and approve exceptions, change controls and CAPAs in the Trackwise module.
Review of data for release APIs, Excipients, and Finished Bulk Product
Perform supplier qualification activities including desk audits and supplier approvals
Author and/or review validation documentation including equipment qualification and process validation
Participate in, or Lead Root Cause Analysis teams
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 Compliance Wire training

MINIMUM REQUIREMENTS:

Education:

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

Experience:

Minimum of 5-7 years' experience in Quality Assurance in a pharmaceutical manufacturing environment

Preferred Skills/Qualifications:

Excellent communication and leadership skills
Knowledge of GMP's for Dosage Products
Knowledge of Supplier Quality or Validation Principles
Understanding of basic statistical principles, and regulatory expectations
Knowledge of Quality Systems
Ability to quickly identify, communicate and/or resolve issues
Ability to build relationships with partners
Good verbal and written communication skills

COMPETENCIES:

Dealing with ambiguity, approachability, decision quality, functional/technical skills, integrity and trust. Customer Focus, managing diversity, fairness, managing and measuring work, motivating others.

RELATIONSHIPS WITH OTHERS:

Reports directly to the Plant Quality Manager. Daily interaction with Manufacturing personnel, Focus Factory Managers, and Quality Management members to provide guidance to resolve issues.

WORKING CONDITIONS:

20% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds
80% office environment which includes 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.