Quality Control Lead/Coordinator - Mallinckrodt Pharmaceuticals : Job Details

Job Title

Quality Control Lead/Coordinator

Requisition

JR000014448 Quality Control Lead/Coordinator (Open)

Location

Fenton, MO

Additional Locations

St. Louis, MO

Job Description Summary

Job Description

SUMMARY OF POSITION:

Provide management of lab operations at the Fenton Manufacturing Plant and technical support at a specialist level. Schedules, prioritizes, and coordinates testing of Finished Products, Raw Materials, Intermediates, In-Process, or Stability samples and other operational activities. Provides solutions to a variety of technical problems of moderate scope while performing some data approval or analysis of samples. This position is expected to be self-directed, requiring minimal supervision. This position will provide the laboratory support for testing of finished products, raw materials, intermediates, finished product and stability samples and other operational activities. Responsible for all areas of the laboratory performing as laboratory lead, mentor, and trainer.

ESSENTIAL FUNCTIONS:

* Ensures laboratory follows good documentation practices for the accurate and timely documentation of all activities

* Ensures laboratory follows site HSE Policies

* Assist with establishing and maintaining safe work standards in lab, and identifying and executing safety improvements

* Ensure laboratory cycle times are met to control site inventory and maintain levels of customer support.

* Coordinates stability testing to achieve 100% on-time analysis for all stability protocol testing intervals

* Conducts lab investigations and root cause analysis

* Ability to perform wet chemistry and instrumentation analysis on any finished product, raw material, intermediate, in-process, finished product or stability sample. Subject Matter Expert in product line or laboratory.

* Perform data release of all products, participate in validations, and execute Gage R&R experiments

* Generate and review proposed changes to specifications (SMMs) through the change control system

* Adept at performing instrument maintenance and troubleshooting chromatography issues

* Manages Out of Specification and Exception Investigations providing root cause analysis and corrective/preventative actions

* Develop and provide proper technical training

* Participate in compliance audits and respond to audit observations

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

* LIMS entry, approval, and data release of products

* Performance of wet testing and use of a broad range of analytical equipment

* Able to flex skills to other laboratories based on business need

* Participates in manufacturing/shipping planning meetings to aid in determining laboratory priorities

* Serve as designee during Supervisor's absence

* Ability to troubleshoot equipment and methods

* Design Gage R&R experiments or write validation protocols/reports

* Utilizes lean tools to identify waste and improve laboratory efficiency

* Identification and implementation of cost savings opportunities

* Supports and/or aids in managing projects in the laboratory.

MINIMUM REQUIREMENTS:

Education:

Bachelors Degree in science related field (Chemistry, Biology) or equivalent combination of education, experience, and competencies accepted.

Experience:

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

Preferred Skills/Qualifications:

* Adept at wet chemistry testing and instrumentation

* Extensive Chromatography experience and technical/troubleshooting abilities

* Advanced knowledge of industry principles, practices, standards, theories and concepts

* Excellent technical writing and oral communication skills

* Moderate computer skills and experience with Microsoft Office Suite

* Advanced understanding of application of basic chemistry/analytical principles, theories and concept

* Use of Empower or other chromatography software

* Previous Pharmaceutical experience

* Typically assigned difficult, demanding or complex tasks, which requires independent action and a high degree of initiative

* Previous supervisory or leadership experience

COMPETENCIES:

Informing, Customer Focus, Listening, Perseverance, Organizing, function/technical skills, Comfort around Higher Management, Multi-tasking, Prioritization, Risk Based Decision Making, Managing Diversity, Motivating Others

ORGANIZATIONAL RELATIONSHIP/SCOPE:

Reports to the Plant Quality Manager. Must be self-directed to manage laboratory operations. Operates independently under limited supervision. Determines objectives of assignments for group. Plans, schedules, and arranges all laboratory activities in accomplishing objectives. Contacts involve matters of moderate importance to the organization and include R&D, Marketing, Production Superintendents, Production Engineers, Production Lead Operators, Logistics, Safety and DEA. Frequent internal and occasional external customer contacts on routine matters.

WORKING CONDITIONS:

* 70% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds

* 30% Office environment

* Required to work 8-12 hour shifts, the potential for night, weekend, and holiday work depending on the lab

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.