Job Title

Supv Quality Testing

Requisition

JR000014277 Supv Quality Testing (Open)

Location

St. Louis, MO (Pharma) - USA032

Additional Locations

St. Louis, MO

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 1 or more laboratories that are responsible for the testing of 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:

• Supervise in process to support manufacturing operations schedule

• Ensure laboratory cycle times are met to proscribed turnaround times to ensure continuous operations

• Investigate Out of Specification results, which includes root cause analysis and root cause determination

• Develop and provide proper training to maintain knowledgeable professional staff

• Accomplishes 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 24/7 In-Process lab with a team of 7-10 direct reports. Responsible for employee relations, performance management, recruitment, oversight of compliance adherence, and ensuring 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

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.

Mallinckrodt is a global specialty p harmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.

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

Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.

Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.