Serves as the primary quality control authority for problem identification, resolution, loss reporting and continuous improvement at Marquis XT.
Manages quality control personnel on a day-to-day basis, including development, training, and scheduling.
Ownership of production quality output in all aspects of the manufacturing process.
Plans, manages, and oversees the daily functions, operations, and activities of quality.
Maintain company quality standards.
Review products, processes, and systems on an ongoing basis to determine where improvements can be made.
Actively participate in production meetings with the manufacturing team.
Coordinate with sales and production teams for new product onboarding and development.
Improve reliability of new product development processes by working closely with design engineering.
Help in development and maintenance of Quality and GMP programs and SOPs.
Develop and maintain test procedures to meet regulatory and customer requirements.
Manage calibration program, service requirements, and troubleshooting of lab instrumentation.
Manage retain and stability testing per Marquis and customer standards.
Assists in design and implementation of method and process validations.
Coordinate data management and analysis with Production Manager.
Interacts with customers to identify opportunities to improve quality and establish feedback with manufacturing and development personnel.
Initiates and implements quality improvement activities as appropriate to raise the performance of the plant’s product lines.
Reports to Top Management on quality issues, trends and losses.
Participates in and conducts internal and external quality audits.
Interfaces with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.
Establishes and implements metrics (process capability, control charts, measurement quality) for monitoring Quality Control system effectiveness.
Participates in root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements.
Establishes collection and analysis systems of statistical data to predict trends that will affect improvement of product quality.
Provide information to the site leadership team to ensure all resources required to execute GMP programs.
Participates in new equipment or process risk assessments and validations.
Coordinates with the Leadership team the execution and completion of the mandatory training programs related to GMP’s and regulatory requirements for the site.
QUALIFICATIONS & EXPERIENCE
Bachelors of Science
At least 5 years of prior applicable work experience in a lab.
Working knowledge of safety and environmental standards.
Background with manufacturing methods, process improvement programs and use of standard protocols.
PHYSICAL REQUIREMENTS
While performing the duties of this job, the employee is regularly required to talk or hear, to sit and use hands to finger, handle, or feel; stand, walk; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl occasionally lift and/or move up to 100 pounds.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; outside weather conditions; extreme cold; extreme heat and vibration. The noise level in the work environment is usually moderate to moderately loud.
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