Sr Quality Testing Engineer

Job Title
Sr Quality Testing Engineer
Requisition
JR000013764 Sr Quality Testing Engineer (Open)
Location
St. Louis, MO (Pharma) - USA032
Additional Locations
St. Louis, MO
Job Description
SUMMARY OF POSITION:
The Sr. Quality Testing Engineer is responsible for management of laboratory operations while supporting the Quality Supervisor with management of personnel. This position is self-directed position, requiring minimal supervision while leading, mentoring and training personnel. This position will provide the laboratory personnel technical counseling and support, serving as point of contact for the laboratory regarding Analysts' schedules, prioritizing and coordinating testing of finished products, raw materials, intermediates, in-process, and stability samples and other operational activities. Position provides solutions to a variety of technical problems while performing data approval or analysis of samples. This position may supervise directly or indirectly Quality Analysts responsible for the testing of the raw material, in-process, and finished good product testing and release for various product areas.
ESSENTIAL FUNCTIONS:

• Ensures laboratory follows good documentation practices for the accurate and timely documentation of all activities
• Ensures laboratory follows site EHS Policies and ensures completion of all required training i.e. computerized and instructor led
• Manages Out of Specification (OOSs) and Exception Investigations using root cause analysis and corrective/preventative actions as needed. Execute the technical writing or assist supervisors or designees with technical writings for OOS and EXC
• Maintain Quality Control metrics and monthly reporting for OOS, EXC Triage, providing monthly metric scorecards for analysts to supervisors
• Develop and provide proper technical training to maintain knowledgeable professional Quality Analysts
• Ensure laboratory cycle times are met to control site inventory and maintain levels of customer support by providing schedule adherence numbers for the lab analysts
• Coordinates stability testing to achieve 100% on-time analysis for all stability protocol testing intervals
• Administer data integrity program for the lab, to include execution of monthly reports and abatement of compliance issues
• Execute data release of all products when needed as back up to supervisors
• Generate and review proposed changes to specifications (SMMs) through the change control system
• Participate in compliance audits and respond to audit observations
• Other duties as assigned

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

• LIMS entry, approval, and data release of products
• Occasional performance of wet testing and use of a broad range of analytical equipment
• Participates in manufacturing/shipping planning meetings to aid in determining laboratory priorities
• Plans, schedules and arranges own and others activities in accomplishing department objectives
• Takes a lead role in training/mentoring team
• Serve as designee during Supervisor's absence
• Ability to troubleshoot equipment and methods
• 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:
BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies.
Experience:

• Minimum of 5 - 8 years' experience in Quality Control/ Quality Assurance in a pharmaceutical manufacturing environment. 3+ years' experience and extensive knowledge of wet chemistry, GC/LC, and advanced knowledge of industry principles, practices, standards, theories, and concepts. Proven personnel and project management history. Complete knowledge of pharmaceutical regulations including current GXP, GLP, or GMP requirements. Ability to perform instrument maintenance and troubleshoot chromatography issues. Ability to conduct OOS Investigations providing root cause analysis and corrective action for Out of Specification Results

Preferred Skills/Qualifications:

• Excellent communication and leadership skills.
• Ability to work in and promote a team environment.
• Working knowledge of Six Sigma and/or Lean manufacturing tools.
• Complete understanding and application of principles, concepts, practices, and standards within discipline.
• Ability to lead and influence people. Understanding of basic statistical principles, expert knowledge of validation principles, techniques, and regulatory expectations.
• Knowledge of US and International pharmaceutical manufacturing regulations.

Other Skills:
Root Cause Analysis, Investigation writing, Quality Control/Analytical Laboratory
COMPETENCIES:
Dealing with ambiguity, approachability, decision quality, functional/technical skills, integrity and trust. Customer Focus, managing diversity, fairness, managing and measuring work, motivating others.
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
Reports directly to the Quality Supervisor or Manager. Supervises non-exempt personnel, accomplishes results through coordinating work of laboratory analyst and/or performing laboratory work. Contact with all internal quality, operations, engineering, R&D, Focus Factory Managers, logistics, and safety personnel. Key contact and subject matter expert for analytical and data release issues.
WORKING CONDITIONS:

• 50% Laboratory environment of standing, walking and exposure to Plant products, solvents and reagents, some of which are hazardous or potent compounds
• 50% Office environment which includes sitting for long periods of time and computer use
• May be responsible for 24/7 hour laboratories
• On-call for all responsible laboratories
• May travel to other site locations as needed

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.