Minerals Technologies Inc. (MTI) is a leading, technology-driven specialty minerals company that develops, produces, and markets a broad range of mineral and mineral-based products, related systems and services. MTI serves a wide range of consumer and industrial markets, including household and personal care, paper, foundry, steel, construction and environmental solutions around the world. The company reported global sales of $2.1 billion in 2022.

MTI focuses on two major segments – Consumer & Specialties and Engineered Solutions. 

Our Consumer & Specialties segment offers technologically enhanced products to consumer-driven end markets plus specialty additives that become functional components in a variety of consumer and industrial goods. This segment includes our Household & Personal Care and Specialty Additives product lines. The Household & Personal Care product line provides mineral-to-market products that serve consumer-oriented end markets including Pet Care, Personal Care, Fabric Care, Edible Oil, and Renewable Fuel Purification. Our Specialty Additives product line provides mineral-based technologies serving Paper, Packaging, Sealants & Adhesives, Paint & Coatings, Ceramics, Plastics, Food & Pharmaceutical markets.

Our Engineered Solutions segment offers advanced process technologies and solutions that are designed to improve our customers’ manufacturing processes and projects. This segment includes our High-Temperature Technologies and Environmental & Infrastructure product lines. Our High-Temperature Technologies product line offers specially formulated blends and technologies primarily for Foundry and Steelmaking industries. Our Environmental & Infrastructure product line provides waterproofing, water purification, remediation and other fluid management technologies for critical projects for Remediation, Water Purification, and Infrastructure.

MTI provides a business environment and promotes a culture that encourages all employees to contribute to our success. We have long been committed to the recruitment and advancement of the most talented and qualified people. We recognize that MTI’s ability to provide the highest caliber of products and services is enhanced by a workforce that reflects the diversity of the communities and countries in which we work.

Job Summary:

The Quality Assurance (QA) Manager is responsible for the planning, execution, and overall management of an FDA and GMP regulated Quality Unit which governs the site’s manufacturing, packaging, labeling, testing, and holding activities of goods produced.  This position directly supervises a team of QA Specialists covering a vast functional area centralizing all aspects of product quality, requiring an abundance of knowledge and established interpretation of FDA Quality Systems Approach to Pharmaceutical cGMP Regulations as well as excellent attention to detail in a rapidly growing business environment.

The QA Manager works with cross-functional teams to ensure that (1) full plant staff is adequately trained on cGMP requirements and such is reflected in good standing procedural adherence and documentation practices; (2) all process-related deviation and batch nonconformance events are properly investigated, driving every problem to true root cause, and developing permanent corrective and preventive solutions for elimination of reoccurrence; (3) Quality Systems are complete and effective; (4) the site remains inspection-ready at all times directly relating to execution and accuracy; and (5) the Quality Unit is successful as measured by actual system results, e.g., first pass prime, deviation tracking, agency inspections, third party audits, customer complaints/returns, customer feedback, and more.

Minerals Technologies, Inc. DBA Health & Beauty Solutions’ Lafayette, LA site is a multifaceted plant engaged in the manufacture of specialty ingredients and packaging conversion of consumer finished goods.  Goods manufactured include a wide variety of excipient, cosmetic, and pharmaceutical formulations marketed for topical skincare use in both personal care and pharmaceutical global industries.

Primary Duties & Responsibilities:

• Actively contribute to the safe operation of the site, participating and leading group efforts in safety engagement programs such as 5S, hazard identification, Near Miss reporting, Non-Routine Task Review (NRTR), Job Observation, risk assessment by Residual Risk Reduction (R3) and Failure Modes/Effects Analysis (FMEA) methods, and ergonomic best practices
• Schedule and supervise Quality Assurance personnel workloads, prioritizing quality and business needs, applying useful time management practices
• Measure and monitor QA personnel performance; conduct formal performance reviews
• Measure, monitor, and report monthly Key Performance Indicators (KPIs) to Plant Management
• Identify annual goals/Hoshin objectives with respect to product quality and pre-determined success/continuous improvement criteria of the Quality Unit and the manufacturing site’s applicable Quality Systems
• Provide cGMP training per 21 CFR parts 210 and 211 to plant personnel and contractors, including one-on-one GMP orientation for new hires and annual classroom setting GMP training for full staff
• Coach, mentor, and develop plant personnel into knowledgeable and functional members of the Quality Unit
• Coordinate with functional teams to ensure the site’s core procedural activities impacting quality of manufactured goods comply with MTI quality standards, cGMPs, 21 CFR parts 210 and 211, and ICH (International Conference on Harmonization) pharmaceutical guidelines where applicable:
• Functional teams including, but not limited to, Business Unit (BU), Plant Management, Engineering, Maintenance, Operations, Quality Control, Warehouse, and EHS
• Procedural activities include preventative maintenance, manufacturing, packaging, labeling, testing, and holding
• Monitor the status and overall effectiveness of Quality Systems; identify opportunities for improvement; ensure QA staff executes accordingly per formal actionable documentation:
• Quality Systems including, but not limited to, Customer Complaints, CAPA, Internal Audit, Validation, Change Control, ICH Stability Study, GMP Management Review, Supplier Management, and Mock Recall
• Assigned as Single Point Accountability (SPA) for key decision-making relating to product quality and the above-mentioned quality programs per FDA or applicable agency regulation per product market
• Lead product investigations including, but not limited to, procedural deviations, nonconformances/OOS results, and customer complaints:
• Actively lead Investigations Team to true root cause(s) as part of every investigation; train team to utilize industry-suitable root cause analysis and problem-solving tools, such as 5 Whys, Fishbone Diagram, Cause Mapping®, or Human Error Solutions/Cognitive Root Cause Determination for intricate circumstances
• Differentiate deviation as minor, major, or critical with respect to validated processes and guide/advise teams accordingly in an efficient manner
• Work closely with Engineering, Maintenance, Operations, Quality Control, and Warehouse where applicable to observe, analyze, and troubleshoot problems, identifying alternative and GMP/industry compliant solutions when necessary for resolution
• Develop permanent, sustainable solutions to system problems for corrective and preventive action; work with Management Team to determine attainable timelines and milestones, define deliverables, and support those with Single Point Accountability (SPA) thru implementation
• Measure the effectiveness of investigations and the overall CAPA program, correlating actual improvements implemented and/or investigations closed vs the number of reoccurring events; drive to zero reoccurrences
• Ensure continuous site inspection and audit readiness, meeting internal, regulatory, and customer expectations on a daily basis
• Host FDA inspections, customer, and third-party audits; provide formal responses to findings with effective and sustainable corrective and preventive action plans
• Review customer Quality Agreements; ensure adherence to such agreements approved by the Business Unit (BU); train and advise QA as well as site staff on the observance and execution of Quality Agreements
• Implement a Quality Risk Management System per FDA publication, Guidance for Industry: Q9 Quality Risk Management (FDA, June 2006) and ICH Guideline Q9 on Quality Risk Management (European Medicines Agency/EMA, January 2006).

Qualifications & Requirements:

The requirements listed in the sections that follow are representative of the knowledge, skills and/or abilities required or preferred to perform the duties of this job.  Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions (primary duties) of the job.

Education:        Preferred – Bachelor’s Degree of Science in Chemistry, Biology, or related curriculum

Or

Bachelor’s Degree of Engineering in Quality or related curriculum

Experience:

• Required – 5+ years’ related experience in a pharmaceutical, personal care, or chemical environment
• Required – Demonstrated broad knowledge of current Good Manufacturing Practices and FDA Code of Federal Regulations, specifically Section 21 part 211
• Required – Vast knowledge of FDA Quality Systems Approach, Guidance for Industry dated September 2006
• Required – Demonstrated experience in root cause failure analysis and problem-solving
• Preferred – Demonstrated work experience relating to FDA inspection, formal response, and correspondence
• Preferred – Well-developed industry and business understanding; demonstrated working knowledge of the importance of Voice of the Customer (VOC), including customer requirements and customer feedback
• Preferred – Familiar with FDA Q9 Quality Risk Management, Guidance for Industry dated June 2006 or European ICH Guideline Q9 on Quality Risk Management dated January 2006.

Safety Training:

• Preferred – Knowledgeable in general OSHA safety regulations
• Actively participate as trainer and trainee respective to all government, company, and job-specific safety policies/procedures; attend, accurately interpret, and practice all required training.

Other Knowledge, Skills & Abilities:

• Ability to speak and read English
• Willingness to work as part of a cross-functional team in a manufacturing setting in Lafayette, LA
• Must pass a background check, pre-employment physical, and drug screen
• Excellent interpersonal skills and ability to work in a team-oriented, inclusive, and diverse work environment
• Strong facilitation, leadership, coaching, and communication skills, both verbal and written
• Organizational credibility; able to influence business area and staff managers in decision-making process, using judgment, creativity, and negotiation when necessary
• Analyze information and situations as needed; exhibit a balance between analytical and creative thinking
• Ability to identify/judge the urgency of a situation
• Strong computer skills:
  • High proficiency in Microsoft applications (Word, Excel, PowerPoint, Outlook, and Teams)
  • Preferred – Experience in Oracle and Power BI
• Ability to effectively manage multiple projects and prioritize tasks accordingly, applying time management strategies
• Expected to be adaptable to shifting of work assignments, whether related to scope or priority, and delegating as needed thru direct communication
• Action-oriented for delivering results; must be a self-starter, active and motivated
• Must be able to work effectively and thrive with minimal direction
• Ability to handle high-pressure situations.

Operational Excellence (OE):

• Utilize and implement OE tools to drive efficiency and continuous improvement
• Maintain self- and department-management daily controls including, but not limited to, visual management boards and Leader Standard Work (LSW) to provide progress/current state of work assignments and projects in      real-time
• Willingness to meet OE/Lean objectives as defined in annual company goals/Hoshin objectives
• Highly engaged in Voice of the Customer (VOC) and an advocate of such, driving continuous improvement and especially demonstrating an openness and willingness to comply with customer-specific requirements, special          requests, and approved Quality Agreements whenever feasible
• Preferred – Knowledgeable in Statistical Process Control (SPC) methods and tools.

Conduct:

• High ethical standards; unwilling to compromise on worker safety and regulatory compliance requirements
• Prioritize “Zero is achievable” safety policy in words and actions
• Prioritize “Zero is achievable” customer complaint program
• Maintain confidentiality of written and verbal information pertaining to Minerals Technologies, Inc., its staff, management and participating onsite affiliates
• Compose all correspondence in a professional manner
• High level of integrity, exhibiting a cooperative and dependable demeanor; ability to support and motivate others, promoting a positive work atmosphere
• Agent of change; not satisfied with the status quo and willing to take strong action, challenging conventional ideas to produce results and/or evolve.

Working Conditions:

• Larger part of work duties accomplished indoor of administrative building and plant facilities
• Regularly conduct work in a controlled office environment
• Frequent contact with individuals internal and external to the organization
• Daily exposure to outside plant operating facilities; outside exposure often involves loud noise, moderate dust, and may include exposure to weather conditions
• Exposure to operational areas requires the use of appropriate safety equipment
• Personal protective equipment (PPE) is readily available for employee, contractor, and visitor use.

Work Hours:

• Normal business hours are M-F 8:00 am - 4:30 pm for office personnel
• Flexibility occasionally required to accomplish job duties
• After hours/weekend remote or onsite intermittently necessary.

Travel:

• Not likely during first 6 months of employment
• Infrequent travel may occur domestically as required.

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