Title: Quality Manager
Reports to: Director of Quality and R&D
Direct reports: Quality Supervisor, Laboratory Technician.
The Quality Manager is responsible for the management of all aspects of Quality Assurance and
Compliance, improvement of quality systems and compliance, as well as regulatory and vendor/customer audits in a nutraceutical manufacturing facility.
• Manages the Quality team members to assure compliance with Food Safety, Quality, Regulatory,and cGMP’s throughout the Manufacturing facility.
• Represents the department at operations management, planning and scheduling meetings and advises on feasibility of testing timelines with respect to planning or production requirements.
• Subject matter expert of Food Safety and Quality Systems, Good Manufacturing Practices, HARPC/HACCP and FDA Regulations (CFR 111 and CFR 211).
• Manages the Factory Sanitation program which includes the Master Sanitation Schedule, Internal Audits, Food Safety and Quality Audits, SSOP's, COP programs and Cleaning Chemicals.
• Manages Pest Control programs working cooperatively with vendors to improve pest control
programs and activities.
• Manages the Pathogen Monitoring Program which includes monitoring facility cleanliness and sanitation and taking corrective action on deficiencies in accordance with the PMP.
• Manages the Food Safety Team which includes maintenance of all aspects of the HARPC/HACCP program.
• Participates in facility audits (Customer, Regulatory, and Certification) and Corrective Action responses from the Audits.
• Develops, writes, review and approves SOPs for activities within the department.
• Take primary, personal responsibility for the timeliness, accuracy and integrity of all documentation of tests conducted on the reliability of ongoing processes that are part of our Manufacturing operations.
• Lead the Company’s effort to ensure compliance with all regulatory directives and any necessary corrective actions.
• Reviews and approves all change controls and deviations initiated internally or by any customers.
• Interfaces with suppliers to assure that all quality standards are met.
• Oversees the implementation and documentation and assures that all relevant procedures remain current.
• Develops and coordinates Quality procedures for new and existing products.
• Measures, assesses and follows-up on team performance improvement plans through timely performance evaluations and reviews. Identifies and assures that all necessary training is provided and documented. (Test Procedures, SOPs, Safety and cGMPs).
• Complies with company policies and procedures and maintains regular work attendance.
• Personal responsibility for following safety rules, SOPs and cGMPs guidelines.
• Performs other duties as assigned.
• Bachelor’s degree in Chemistry, Food Sciences, Microbiology, Engineering (Industrial or Chemical)
• Minimum five (5) years’ experience as a Quality Assurance professional in a pharmaceutical or nutraceutical manufacturing environment.
• Demonstrate a solid knowledge of Quality Assurance practices and procedures, certification schemes, preferably SQF, BRC, ISO 22000, ISO 13485 and CFR111, 121 and 211. Experience in the implementation and maintenance of cGMPs is preferable.
• Proficient in MS Office Suite (Word, Excel, Power Point, etc…)
• High level of interpersonal skills, coupled with equally strong leadership abilities and organizational and time management skills
• Excellent communication and documentation skills
• Ability to work independently and meet deadlines