Supv Quality Testing

2 weeks ago

St Louis, United States Mallinckrodt Pharmaceuticals Full time

Description

SUMMARY OF POSITION:
Supervise product and stability Quality Control (QC) testing groups and compliance activities to achieve key site and corporate objectives. Specifically, this role will oversee one or more laboratories that are responsible for the testing of the raw material, in-process product, and finished good products, some laboratories operate under a 24/7 work schedule. Responsible for the release of intermediates, stability, and finished product for various product areas.

ESSENTIAL FUNCTIONS:

Ensure laboratory cycle times are met to control site inventory and maintain levels of customer support. Supervise stability testing to achieve 100% on-time analysis for all stability protocol testing intervals Investigate Out of Specification results, which includes root cause analysis and root cause determination Develop and provide proper training to maintain knowledgeable professional staff Accomplish results through subordinate non-exempt employees Participate in compliance audits and respond to audit observations Hold group accountable for following site Environmental Health and Safety (EHS) standards Supervise a team of 8-12 direct reports, Responsible for employee relations, performance management, recruitment, oversight of compliance adherence, and ensures tasks are completed accurately and on schedule.

MINIMUM REQUIREMENTS:
Education: BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies.

Experience: 5 years related experience; working knowledge of GMP's and GLP's.

Preferred Skills/Qualifications: Proven experience in providing direction to subordinates using established policies and precedents.

Other Skills: Root Cause Analysis, Investigation writing, Quality Control/Analytical Laboratory.

CORE COMPETENCIES:

Customer Focus, Managing Diversity, Fairness to Direct Reports, Functional/Technical Skill, Integrity and Trust, Managing and Measuring Work, Motivating Others.

RELATIONSHIP WITH OTHERS:

Supervises non-exempt personnel, accomplishes results through coordinating work of laboratory analyst. Contacts including R&D, Focus Factory Managers, Logistics, and Safety. Key contact and subject matter expert for analytical and data release issues.

WORKING CONDITIONS:

50% Laboratory exposure to plant products, solvents, reagents, some of which are hazardous or potent compounds. 50% Office environment which requires sitting for long periods of time and computer use.

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