Manager Quality Systems

Manager Quality Systems

Position Summary

Greendale is one of Catalents gummy technology development and manufacturing facilities in North America. The site manufactures organic and veganbased nutraceuticals via confection to enhance wellness for all consumers. Simply put we make healthy gummies. Within the Catalent network we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.

The Manager Quality Systems is responsible for the creation and maintenance of the Quality System documentation. Communicate any deviations to management. The Manager Quality Systems will assist the Quality Assurance team with special projects as required. Comply with SQF Food Safety Plan (HACCP) Food Quality Plan (FQP) standards.

The Role

• Subject Matter Expert (SME) for SQF FSMA/HACCP and 21 CFR 111 Standards and implementation.

• SQF Practitioner and FSMA PCQI lead for the site.

• Responsible for validation of the Food Safety Preventative Controls.

• Manage and report on the Environmental Monitoring program performance and corrective actions.

• Manage trend and report Customer Complaints and lead investigations for completion of Customer CARs.

• Support the creation and maintenance of all documentation related to the Quality System utilizing technical writing skills to ensure proper formatting numbering and organization of all related documents: MMRs specifications BPRs Food Safety and Quality Plans and any other documents as required.

• Manage the internal plant routing and approval process for new documents and process deviations.

• Lead the internal audit program by managing the internal audit schedule training of internal auditors performing internal audits and inspections and documenting all areas of nonconformance to support continuous improvement efforts and ensure corrective actions are implemented to eliminate them.

• Responsible to completion and response to all Customer related Nonconformance reports.

• Work with Production and Packaging Managers Supervisors and R&D to maintain and update records and documentation

• Other duties as assigned

The Candidate

• Bachelors degree in Food Science Biology Chemistry or other related major required.

• 5 years of experience in a GMP facility in a managerial role required.

• SQF Practitioner with implementation experience required.

• FSMA Preventative Control and Qualified Individual (PCQI) and HACCP trained within the last 3 to 5 years with experience implementing and validating Food Safety programs required.

• Experience implementing cGMP and 21 CFR 111 Standards is a plus.

• Experience implementing and managing Environmental Monitoring Programs.

• Knowledge of NLEA labeling requirements is a plus.

• Supplier Auditor certification preferred

• For business and safety reasons must be able to communicate effectively verbally and in written English.

• Ability to communicate with all line level positions and management

• Strong interpersonal skills are essential. Ability to develop cross functional and multinational relationships to support interaction with various internal customers.

• The employee must be able to lift and/or move up to 25 pounds. While performing the duties of this job the employee is required to use hands to finger handle or feel and is frequently required to stand walk reach with hands and arms stoop kneel crouch or
  crawl and talk or hear. The employee is required to sit climb or balance and taste or smell.

Why you should join Catalent

• Diverse inclusive culture

• Competitive salary

• 401(k) retirement savings plan with company match

• Educational assistance/reimbursement

• 152 hours of paid time off 8 paid holidays

• Medical dental and vision insurance

• Life insurance

• Wellness programs

• Flexible spending account

• Employee discount programs

• Robust employee referral program