OVERVIEWThe Corporate Quality Manager - Laboratories is responsible for the standardization of laboratory operations across the enterprise including instrument selection, methods of analysis, proficiency testing support and guidance, and general laboratory design and personal practices. Additionally, the position leads the coordination of third-party testing to support supplier qualification and monitoring, unique finished product testing, and other unique testing which is not a part of the capabilities of the operating facilities. The incumbent is also responsible for maintaining awareness of and understanding of pharmaceutical / national formulary (NF) / USP monographs and methods and supporting those sites which manufacture products to these standards. Responsibilities also include the use of laboratory scale testing to evaluate process aids, chemicals, and existing and alternate process technologies and support technology transfer for in-line measurement.
GEOGRAPHIC SCOPEREQUIRED EDUCATION & WORK EXPERIENCE- Bachelor's Degree in a scientific discipline from an accredited university plus at least 5 years of commercial laboratory or industrial operations experience
- Knowledge of Quality Assurance/Control practices and procedures
- Experience in communicating with 3rd party labs and suppliers
- Previous leadership / supervisory experience in a manufacturing environment
- HACCP and/or related food safety training
- Knowledge of the operation and calibration of laboratory equipment
PREFERRED EDUCATION & WORK EXPERIENCE- Degree major in Chemistry, Biology, or Food Science is preferred
- Knowledge and understanding of sugar refining technologies and required process aids
- Experience in ISO/IEC 17025 implementation and maintenance of accreditation
- Continuous Improvement (CI) knowledge and experience (i.e. Lean Six Sigma, Black/Green/Yellow Belt, 5S, etc.)
TRAVEL- 20-40% primarily in North America including short notice travel requests.
POSITION RESPONSIBILITIES- Establish and maintain standards for ASR site quality laboratories in terms of procedures, equipment employed and overall appearance and operation
- Establish, maintain, and monitor unique testing for specific customers (i.e. quarterly & annual testing)
- Support the laboratory proficiency testing program which ensures methods and analysts are evaluated on an annual basis
- Establish and maintain an internal laboratory auditing program.
- Lead the Laboratory Community of Practice which includes Laboratory Supervisors and other Quality team members from the operating sites.
- Work collaboratively with the Supplier Quality team in the coordination of third-party testing for supplier qualification / monitoring and with the operating sites for specific finished product monitoring.
- Champion standards for any site laboratory renovation projects in cooperation with Corporate & site Engineering along with site Quality and Laboratory leaders.
- Process aid and process technology modeling and testing
- Quality testing method development, validation, and standardization
- Support of new product development initiatives and test methods for these products
- Routine interaction with Research & Technology (R&T) & Boca Raton Innovation Center (BRIC)
- Maintain and act as ASR technical liaison in matters concerning the pharmaceutical (NF/EP/USP/etc.) business
- Provide technical training to laboratory, manufacturing and general staff as required
- Complete laboratory testing for corporate samples as required
- Performs other duties as assigned
ESSENTIAL ABILITIES & CRITICAL SKILLS- Ability to analyze complex information and perform root cause analysis
- Ability to recognize areas for Continuous Improvement strategies; recommend and implement CI strategies as assigned
- Ability to utilize ERP information and analyze results
- Ability to maintain confidentiality of proprietary business information at all times
- Ability to effectively manage time, including the ability to prioritize, work within assigned deadlines, and work independently or collaboratively to accomplish organizational objectives
- Ability to manage multiple tasks and projects while maintaining quality & accuracy standards
- Ability to utilize Microsoft Office Suite, specifically Excel, Word, and Outlook on an Advanced Level
- Ability to communicate in a clear and concise manner both verbally and in writing, fostering strong lines of communication across the business
- Leadership
- Quality Management
- Acting Strategically
- Planning & Scheduling
- Problem-Solving
- Analytical Thinking
PERSONAL ATTRIBUTES- Managing Complexity- Keeping focused on key objectives and results when addressing the details of a situation. Making timely decisions using available facts in ambiguous situations.
- Regulatory Matters- Demonstrates understanding of regulatory and compliance requirements for area of responsibility.
- Working with Ambiguity- Achieves forward progress in the face of poorly defined situations and/or unclear goals; able to work effectively with limited or partial information.
- Accountability: Takes accountability for delivering on commitments; owns mistakes and uses them as opportunities for learning and development; openly discusses his/her actions and their consequences both good and bad.
- Credibility - Adheres to a set of core values that are represented in decisions and actions. Does the right thing, even when it is difficult. Demonstrates technical proficiency, reliable customer service and delivery of results in supporting clients; speaks with authority and is respected by others; maintains objectivity in dealing with issues. Removes/ minimizes bias from decisions.
- Quality Management- Knowledge and application of food industry quality systems; Knowledge and application of procedures required for testing food quality.
- Acting with Integrity: Clearly states goals and beliefs; lets people know his/her true intentions; does what he she said they would do; follows through on commitments; Understands and follows company policies
- Communication & Interpersonal Skills: Expresses ideas and information in a clear and concise manner; tailors message to fit the interests and needs of the audience; delivers information in a manner that is interesting and compelling to the listener
- Energy & Initiative: Takes action on his/her own without being prompted; handles problems independently; able to resolve issues without relying on extensive help from others; does more than is expected or asked; asserts one's influence over events to achieve goals
- Judgment & Decision-Making: Bases decisions on a systematic review of relevant facts and information; avoids making assumptions or rushing to judgment; provides clear rationale for decisions
- Customer Orientation - Addressing internal and/or external customer needs by providing and delivering professional, helpful, high-quality service and support
