Quality Control Manager in Quakertown

Job DescriptionJob Description

The QA/QC Manager will provide leadership and direction to ensure the day-to-day quality system and programs are aligned with operational execution. Monitor and ensure that operations are conducted in compliance with FDA regulations and meeting cGMP and other applicable regulatory requirements. Monitoring, Directing, and coordinating all Manufacturing Operations, Pharmaceutical Development activities, Process Validation, Packaging Validation, Cleaning Validation, Technical Services Operations, Maintenance and Engineering activities. This individual will oversee a team that monitors operations to identify opportunities and improvements to reduce risks to GMP compliance and secure business. This individual will build strong partnerships with Operations, QC, Engineering, and Maintenance staff to ensure compliance with site and FDA requirements, ensuring customer demands are met as well as cGMP's specific to the site. Additional duties are listed below:

• Maintains an industry standard level of quality throughout the organization.
• Has a general knowledge of the manufacturing operation and equipment, passivation, and inspection of equipment.
• Understands material process flow and traceability,
• Crafts manages, and maintains standard operating procedures.
• Manages internal and external quality, environmental, and safety audits.
• Manages customer complaints, deviations, and investigations.
• Manages quality and laboratory personnel.
• Manages training and mentoring of manufacturing, quality, and laboratory personnel.
• Conducts quality review of production batch records.
• Inspects and releases finished goods.
• Inspects manufacturing equipment and production stations.
• Ensures preventive maintenance is performed.
• Adheres to GMP;s and GDP's.
• Other quality related tasks as needed.

QUALIFICATIONS

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• The requirements listed below are representative of the knowledge, skill, and/or ability required.

EDUCATION AND EXPERIENCE

• The candidate will have a BS in related engineering or applied science; equivalent combination of education and experience considered
• 5+ years pf quality management experience. Experience with FDA (food and pharmaceutical) .

SPECIFIC COMPETENCY

• : Excellent ability to read, write, speak and understand English
• MATHEMATICAL: The ability to apply algebraic and statistical tools for analysis of product and process.
• Use of MS Office software including Word, Excel, Access, PowerPoint.
• Ability to write and edit technical instructions that are clear and effective.
• Ability to produce product documentation as required

Company DescriptionParticle Size Technology Inc recognizes that the disciplines of quality, health and safety, and environmental management, are an integral part of its management function. The company involves their employees in the continual development process, complies with all applicable laws and regulations, consistently meets or exceeds our customers expectation though continued education and innovation.Company DescriptionParticle Size Technology Inc recognizes that the disciplines of quality, health and safety, and environmental management, are an integral part of its management function. The company involves their employees in the continual development process, complies with all applicable laws and regulations, consistently meets or exceeds our customers expectation though continued education and innovation.