Quality Control Manager

Particle Size Technology Inc; Quakertown (Bucks County); On-site; USD 110,000 - 170,000; Full time

Job summary

Particle Size Technology Inc. seeks a QA/QC Manager to lead the day-to-day quality system, ensuring FDA compliance and cGMP standards across operations.

The role oversees Manufacturing, QC, Engineering, and Maintenance, guiding process validation, packaging validation, and audits while driving risk reduction and product quality improvements.

Qualifications

• The candidate will have a BS in related engineering or applied science.
• 5+ years quality management experience; FDA experience preferred.

Responsibilities

• Maintains an industry standard level of quality throughout the organization.
• Manages internal and external audits, customer complaints, deviations, investigations.
• Oversees training and mentoring of manufacturing, quality, and laboratory personnel.
• Inspects and releases finished goods; ensures GMP/GDP compliance.
• Directs manufacturing operations and validation activities.

Skills

English proficiency

Quality management

Regulatory compliance

Auditing

Training leadership

Education

BS in related engineering or applied science

Tools

MS Office

Statistical tools

Job description

Job 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) preferred.

SPECIFIC COMPETENCY

• LANGUAGE: 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 Description

Particle 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 Description

Particle 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.