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Sr. Quality Specialist II- Quality Systems and Organizational Improvements

Date: Aug 6, 2019

Location: Coventry, RI, US, 02816

Company: Purdue Pharma L.P. & Affiliates

Job Summary

This position will be a key change agent in initiating, leading and/or supporting activities related to driving continuous improvements in the Quality Organization, resulting in strengthening of the overall Quality compliance posture and improving performance for the Rhodes Technology business. The Sr. Quality Specialist will work with Quality and individuals from other departments to define process improvements and drive change on specific projects.

Primary Responsibilities

Identify opportunities for Quality unit improvements and make recommendations to Site Leadership.

Support teams assigned to assist with the implementation and drive projects to conclusion.

Facilitate communications and change management for key programs and projects.

Encourage a culture of continuous improvement by influencing and empowering employees to identify opportunities in their daily work activities.

Identify key elements of process improvements and partner with process owners to deliver sustainable and repeatable change.

Education and Experience

BS in Life Science (chemistry or pharmacy) with 10+ years of increasing responsibility in the FDA regulated manufacturing environment.  Prior experience in API manufacturing preferred.  Experience with leading complex operational transformation, project management, facilitating organizational alignment, goal setting, change management practices and prioritizing improvement initiatives within and across an organization.

Necessary Knowledge, Skills, and Abilities

Ability to work cross-functionally with department heads and staff, including R&D, Technical Services, Manufacturing, Regulatory Affairs, Materials Management, and Human Resources.

Strong knowledge of GMP-related disciplines such as manufacturing, API development, technology transfer and quality control.

Thorough knowledge of quality and GMP processes.

Ability to act as a functional expert with minimal need for guidance on complex issues.

Microsoft Office: Microsoft Word, Excel, PowerPoint, Project and Visio preferred

Excellent verbal and written communication skills

Excellent organizational skills

Supervisory Responsibilities (if Applicable)


Additional Information

Nearest Major Market: Providence
Nearest Secondary Market: Rhode Island

Job Segment: Law, Compliance, QC, Project Manager, Quality, Legal, Technology