Supv Quality Control

Posted 2 Days Ago
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Fenton, MO
Senior level
Healthtech • Pharmaceutical • Manufacturing
The Role
Supervise and ensure compliance of QC testing groups, oversee laboratory operations for product testing, manage a team, conduct root cause analyses, ensure customer support is maintained, and participate in compliance audits.
Summary Generated by Built In

Job Title

Supv Quality Control

Requisition

JR000014645 Supv Quality Control (Open)

Location

Fenton, MO

Additional Locations

Job Description Summary

Job 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 testing to achieve 100% on-time analysis.
  • 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 5-7 direct reports, Responsible for employee relations, performance management, recruitment, oversight of compliance adherence, and ensures tasks are completed accurately and on schedule.
  • Other duties as assigned with or without accommodation.

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.

Must be familiar with chemical and pharmaceutical manufacturing operations and techniques. 

Preferred Skills/Qualifications: Proven experience in providing direction to subordinates using established policies and precedents. Root Cause Analysis, Investigation writing, Quality Control/Analytical Laboratory.

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

RELATIONSHIP WITH OTHERS/ SCOPE:

  • 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.

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.

Top Skills

Glp
Gmp
Quality Control
Root Cause Analysis
The Company
Bridgewater, NJ
3,383 Employees
On-site Workplace
Year Founded: 1867

What We Do

At Mallinckrodt, we use strategic vision and employee-driven momentum to pursue a powerful mission: Listening for needs and delivering solutions.

As a leader in specialty pharmaceuticals, we develop, manufacture, market and distribute innovative treatments for underserved patient populations within neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes and gastrointestinal products. . Our expertise also extends into acute and critical care hospital products, as well as our broad portfolio of generic prescription medicines and active pharmaceutical ingredients.

Together, we’re helping shape the future of the specialty pharmaceuticals industry by leveraging the values our founders instilled over 155 years ago – quality, integrity and service.

To learn more about Mallinckrodt, visit www.mallinckrodt.com.

Equal Opportunity Employer
Mallinckrodt Pharmaceuticals 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 genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. 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.

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