Job Description:
Responsible for managing the Regulatory aspects of innovative products and services for Santa Cruz Nutritionals (SCN). The individual must effectively collaborate with other members of Quality Assurance (QA), Quality Control (QC), Change Control, Sales, and Marketing to ensure the products and services are planned and implemented compliant with Good Manufacturing Practices (cGMP) expectations of the applicable regulatory authority. The individual will also operate independently with respect to supporting the quality aspects of the products and services from an analytical, validation, and processing perspective. Additionally, the individual must be creative with respect to ensuring compliance of novel products and services.
Compensation/Salary:
DOE
Requirements:
- Bachelor’s Degree in a Scientific field.
- 5 years’ experience in regulatory and compliance within the food/pharmaceutical industry.
- 2 years’ experience in a leadership role.
- Knowledge of FDA 21CFR111 Quality System Regulations, required.
- Knowledge and experience in interpreting and applying FDA regulations, policies, and procedures.
- Basic knowledge of human resource practices.
- Advanced skill in verbal and written communication.
- Intermediate skills with Microsoft Excel, Word, PowerPoint, and Outlook
- Basic skill in Microsoft SharePoint
- Self-starter with strong, proactive work ethic.
- High level of attention to detail.
- Ability to manage multiple projects simultaneously to meet deadlines.
- Ability to collaborate and influence cross-functional colleagues.
- Project management experience preferred.
Responsibilities & Duties:
- Create validation documentation for manufacturing processes and cleaning protocols for the Dietary Supplement manufacturing processes.
- Lead regulatory compliance support activities including but not limited to government agency audits, supplier quality and corrective action plans, claim substantiations, and dietary supplement label review.
- Leads effort in the selection and implementation of a comprehensive Quality & Continuous Improvement to include management of Non-conformances, Batch Investigation, tooling & equipment management, document control, customer service, supplier management, auditing, and development of an employee training program.
- Training: Responsible to manage and lead quality related regulatory training throughout the company.
- Responsible for tracking all training throughout the company.
- Write and revise departmental Standard Operating Procedures (SOP’s). Review and approve documentation associated with Production, QC, Validations, Change Control, non-conformances and SOP’s.
- Responsible for overseeing the Supplier Qualification Program.
- Document Control and lot review and release.
- Develop manufacturing process flow diagrams and process validation procedures. Evaluate process capability and identify needs for improvement.
- Leads Internal Audits, inspections and verification of affectivity.
- Corrective Action and Preventative Action (CAPA) Management
- Provide timely support of batch review and batch investigation.
- Member of Change Control and Material review.
- Serves internal and external customers by establishing critical service factors; maintaining quality service and operations; defining and developing quality systems and resources.
- Works directly with the customer developing, quality agreements, product dossiers, stability and label agreements.
- Regulatory review of all finished product labels.
- Files for site licensing as required (Health Canada).
- Represents Regulatory department in the support of Supplier Development including the performance of supplier quality system audits, and assisting suppliers to meet compliance requirements
- Develop and execute process validation strategies.
- Maintains professional and technical knowledge by attending education workshops and reviewing professional publications.
- Other duties as assigned.