Group Leader Quality Control Analytical

Looking for a career where you can make a difference?

At Mary Kay we are committed to enriching the lives of women and their families around the world, we offer careers with unlimited opportunities to do something beautiful every day.

More than 5,000 employees work in locations around the world. They provide the products, marketing and other support to millions of Independent Beauty Consultants (IBCs) who work as independent contractors, selling our products directly to consumers in nearly 40 markets on five continents.

We are a company that believes in our people and cares for them with truly exceptional benefits. We offer :

• A comprehensive health plan which includes medical, dental, and vision with low premiums
• 401(k) plan
• A generous profit-sharing program
• Free access to on-site fitness center and on-site clinic

Summary

Accountable for planning, scheduling, developing, coordinating work and supervising the laboratories which perform quality inspection testing of all incoming raw materials, bulk, finished goods, , validation and cleaning swabs both contract and internal production.

This is to ensure that all products manufactured by or for Mary Kay Inc. meet the quality standards necessary to support corporate goals and policies and be done so in an FDA compliant manner.

Conducts analyses of bulk products, raw materials and finished goods to determine compliance with quality control specifications to facilitate managerial decision-making in the QC Analytical department.

Facilitate training to QC personnel in Good Laboratory Practices, techniques and procedures to ensure competencies. Possesses strong technical expertise in Analytical Chemistry providing oversight, technical expertise and guidance to QC personnel.

Anticipates and stays abreast of industry technology and regulatory compliance related to Quality Control testing.

Responsibilities

Supervises the analytical quality inspection and audit function. Plans, initiates, and supervises the systematic inspection and analysis of bulk products and raw materials to meet defined objectives.

Develops systems and implements new methods and procedures to improve efficiency and flexibility of all QC Analytical operations.

Develops metrics, monitors results, and implements systematic improvements as needed to meet strategic objectives. Provides technical direction to staff members.

Maintains or implements quality systems to ensure compliance with FDA regulations and business objectives. Interfaces with Supervisors, Managers and Directors of Production Operations, Research and Development, Marketing, Contract Services, Planning, and Distribution by responding to in-house technical questions, problems related to product quality and release status.

Serves as in-house expert and liaison to other functional units by responding to technical questions related to product quality, statistical data analysis, statistical quality control, sampling plans, or quality methods.

Conducts out-of-spec (OOS) investigations according to established procedure and ensures the timely gathering of all relevant data to aid the Quality teams or other departmental personnel with investigation closure.

Effectiveness is measured through KPI’s such as turnaround time, compliance and prevention of repeat quality issues. Monitors and measures team performance and identifies technical training requirements for staff.

Plans and coordinates activities for the QC Analytical department by creating and refining the structure and framework of the department, manages risk, and ensures goals are accomplished in accordance with prescribed priorities, time limitations, and funding conditions.

Provides technical direction and supervision to direct reports to help meet established schedules and / or resolve technical or operational problems.

Ensures ongoing training, competency assessment and development of staff. Coaches staff and provides succession planning;

prepares and administers performance reviews, coordinates workload; and develops and maintains a safe, positive working environment for the department.

Execute tasks as assigned to improve laboratory efficiency.

Supervises the QC Analytical FDA compliance function including batch and test record review, collection of legal retains, system suitability, and control sample testing.

Checks and verifies the analytical results generated by the laboratory staff, including data to support process validation studies and investigative work.

Ensures that the operations of the laboratory are conducted under GMP compliant conditions. Develops systems and implements new methods and procedures to improve efficiency of all QC Analytical operations.

Oversees the operation and maintenance of lab equipment used in the testing of bulk products, raw materials, finished product samples, validation samples, water samples, environmental monitoring samples and troubleshooting samples Typical equipment includes HPLC, GC, FTIR, UV-VIS, pH meters, viscometers, pycnometer, densitometer, TOC analyzer, sieve analysis, particle size analyzer and analytical balances.

Maintains appropriate calibration and maintenance records for all instrumentation. Performs or oversees the IQ / OQ / PQ of analytical instrumentation when appropriate.

Coordinate external equipment maintenance and ensure current vendor contracts.

Acts as a liaison to resolve product quality, technical or operational issues and support APR of OTC products. Works with Plant Operations groups, Process Development & Commercialization, Purchasing and Quality Engineering to investigate external and internal quality and compliance related issues.

Works to resolve these issues with QC staff and high-performance teams as required. Develops and recommends solutions to prevent future occurrences and implement continuous improvements.

Follows up to verify that changes in the systems are implemented and monitors the systems over time to verify improvement.

Proactively identifies and implements policies, procedures and processes to continuously improve the product and compliance quality of Mary Kay, Inc.

Makes changes as necessary.

• Contributes to the preparation of an annual budget of approximately $1M. Monitors and approves expenditures for the laboratory cost center and monitors costs to ensure compliance with budget limitations.
• This job requires on-site work at a Mary Kay facility.

Skills & Experience

Experience : 5+ years

Supervisory Experience : 3+ years

Field of Experience : Experience in a senior level scientist position and 3+ years of supervisory experience or demonstrated leadership / management skills.

Certification by the American Society for Quality (ASQ) as a Certified Manager of Quality / Organizational Excellence (CMQ / OE), Certified Quality Auditor (CQA), or Certified Quality Engineer (CQE) is strongly preferred.

Skills & Abilities

• Must possess strong technical and analytical skills.
• Must have a good understanding of advanced quality principles, of audit protocol, inspection procedures and FDA and GMP regulations.

Must be familiar with compliance requirements for over the counter (OTC) products and similar globally.

• Must have the ability to apply advanced principles, theories, and concepts and contribute to the development of new principles, systems and concepts.
• Must be able to provide solutions to a wide range of difficult and complex problems which require the regular use of ingenuity and creativity.

Solutions should be imaginative, thorough and practicable.

• Must have excellent oral and written communications skills, tact, diplomacy and high level of professionalism to facilitate communication among various groups to achieve quality objectives, influence management decisions, and effectively interact with all levels of personnel within and outside the Company
• Must display strategic thinking, creativity, analytic ability, strong execution skills and possess excellent project management skills (planning, organizing, communicating, and directing) to perform a wide variety of activities simultaneously.
• Must have the ability to perform duties under very general direction and independently perform assignments with only general criteria for expected results.

Must have excellent project management skills to perform and prioritize a wide variety of activities simultaneously.

• Must have the ability to lead, mobilize and inspire a diverse group of analytical chemists and technicians.
5 days ago