Santa Cruz Nutritionals
Quality Compliance Program Manager
Santa Cruz Nutritionals, Santa Cruz, California, us, 95061
We believe being healthy should not require tradeoffs. SCN BestCo is a leading innovator, developer and manufacturer of Vitamin, Mineral & Supplement (VMS), Over-the-Counter (OTC) and prebiotics/probiotics in enjoyable forms such as gummies, lozenges and chews. With over 50 years of excellence, our team leads the way in changing how consumers make healthier choices. With unique food science expertise and proprietary processes, we've pioneered many firsts. The fire in our belly to create new to the world products has guided and continues to be core to our mission of making health and wellness more enjoyable. Come join us and become a part of our winning formula!
The Quality Compliance Program Manager independently verifies processes, products, and systems against standards to determine compliance. This position creates, develops, and improves internal auditing programs, leads external audits, and oversees the Corrective and Preventive Action (CAPA) program. Responsibilities include the development and presentation of metrics to drive compliance and driving Quality continuous improvement projects as needed.
Estimated starting annual base salary is $112,717.99 - $169,076.98 per year less applicable withholdings and deductions, paid on a bi-weekly basis. Please note that the actual compensation offered may vary based on relevant factors as determined by the Company, which may include, but is not limited to, location, experience, qualifications, education, skillset, and market conditions. The target base compensation for this role is in the low to middle of the range, with the top of the range reserved for only exceptional circumstances. In addition, this role is eligible for a discretionary, variable annual incentive, paid based on Company performance factors. SCN BestCo offers a competitive benefits package to eligible full-time employees, which currently includes medical, dental, and vision plans, 401(k) with employer matching contributions, life insurance, paid time off, tuition reimbursement, and more, as well as paid sick leave in accordance with applicable law. Each benefit is subject to eligibility requirements as specified in plan documents, and the Company reserves the right to modify the benefits it offers from time to time.
Essential Duties and Responsibilities
Oversee all internal audit phases (preparation, performance, reporting, follow-up, and closure).Prepare, support, and lead all third-party audits (customer, NSF, Gluten Free, Kosher, SQF, GFCO, etc.) at the facility.Support FDA inspections and lead any follow-up action items resulting from the inspection.Maintain understanding of the standards and principles of auditing, related techniques (examining, questioning, evaluating & reporting) to determine adequacy of relevant resources.Audit internal documents, reports, and systems for accuracy.Analyze audit data to identify trends and issue reports and recommendations to management.Ensure audit records are complete and accurate.Lead CAPA Board meetings and ensure follow-up on all CAPAs to closure.Develop and present metrics around audits and CAPAs.Create and revise Standard Operating Procedures (SOPs) and Work Instructions (WI) as necessary.Required Qualifications
Education & Experience:
Bachelor's degree in food science, technology, biology, microbiology, or other related discipline.6 years' professional Quality Assurance/Control experience.3 years' experience supporting quality audits, such as facilitating, coordinating, scheduling, scribing, etc.Knowledge, Skills, & Abilities (KSAs):
Thorough knowledge of cGMP documentation requirements and quality systems.Advanced skills with Microsoft Office applications.Strong organizational and time management skills.Must have ability to collaborate and work well with cross-functional team members (e.g., regulatory, production, and maintenance).Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.Must have effective verbal and written communication skills and ability to communicate well with internal staff and management. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of an organization.Must be able to demonstrate practical problem-solving and troubleshooting skills. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.Preferred Qualifications
Master's degree in science, Regulatory Affairs, Quality Assurance, or related discipline.Knowledge of NSF, USP, Non-GMO, Gluten-Free, Organics Programs and relevant government regulations.Knowledge of 21 CFR 111 and 21 CFR 117Experience with FDA Inspections.Certified Quality Auditor (CQA).Bilingual in English/Spanish.
The Quality Compliance Program Manager independently verifies processes, products, and systems against standards to determine compliance. This position creates, develops, and improves internal auditing programs, leads external audits, and oversees the Corrective and Preventive Action (CAPA) program. Responsibilities include the development and presentation of metrics to drive compliance and driving Quality continuous improvement projects as needed.
Estimated starting annual base salary is $112,717.99 - $169,076.98 per year less applicable withholdings and deductions, paid on a bi-weekly basis. Please note that the actual compensation offered may vary based on relevant factors as determined by the Company, which may include, but is not limited to, location, experience, qualifications, education, skillset, and market conditions. The target base compensation for this role is in the low to middle of the range, with the top of the range reserved for only exceptional circumstances. In addition, this role is eligible for a discretionary, variable annual incentive, paid based on Company performance factors. SCN BestCo offers a competitive benefits package to eligible full-time employees, which currently includes medical, dental, and vision plans, 401(k) with employer matching contributions, life insurance, paid time off, tuition reimbursement, and more, as well as paid sick leave in accordance with applicable law. Each benefit is subject to eligibility requirements as specified in plan documents, and the Company reserves the right to modify the benefits it offers from time to time.
Essential Duties and Responsibilities
Oversee all internal audit phases (preparation, performance, reporting, follow-up, and closure).Prepare, support, and lead all third-party audits (customer, NSF, Gluten Free, Kosher, SQF, GFCO, etc.) at the facility.Support FDA inspections and lead any follow-up action items resulting from the inspection.Maintain understanding of the standards and principles of auditing, related techniques (examining, questioning, evaluating & reporting) to determine adequacy of relevant resources.Audit internal documents, reports, and systems for accuracy.Analyze audit data to identify trends and issue reports and recommendations to management.Ensure audit records are complete and accurate.Lead CAPA Board meetings and ensure follow-up on all CAPAs to closure.Develop and present metrics around audits and CAPAs.Create and revise Standard Operating Procedures (SOPs) and Work Instructions (WI) as necessary.Required Qualifications
Education & Experience:
Bachelor's degree in food science, technology, biology, microbiology, or other related discipline.6 years' professional Quality Assurance/Control experience.3 years' experience supporting quality audits, such as facilitating, coordinating, scheduling, scribing, etc.Knowledge, Skills, & Abilities (KSAs):
Thorough knowledge of cGMP documentation requirements and quality systems.Advanced skills with Microsoft Office applications.Strong organizational and time management skills.Must have ability to collaborate and work well with cross-functional team members (e.g., regulatory, production, and maintenance).Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.Must have effective verbal and written communication skills and ability to communicate well with internal staff and management. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of an organization.Must be able to demonstrate practical problem-solving and troubleshooting skills. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.Preferred Qualifications
Master's degree in science, Regulatory Affairs, Quality Assurance, or related discipline.Knowledge of NSF, USP, Non-GMO, Gluten-Free, Organics Programs and relevant government regulations.Knowledge of 21 CFR 111 and 21 CFR 117Experience with FDA Inspections.Certified Quality Auditor (CQA).Bilingual in English/Spanish.