Compliance Specialist
Threshold Enterprises, Scotts Valley, CA, United States
Threshold Enterprises®, established in 1978, is a leading wholesale distributor of dietary supplements and health care products to the natural foods industry and health professionals. As the parent company of Source Naturals® and Planetary Herbals®, Threshold Enterprises® is recognized for its commitment to improving health and well-being. The company is based in Santa Cruz County, California, and is known for being a top employer in the region. With a supportive work environment, Threshold Enterprises® offers exciting career opportunities across various fields.
Role Description The Quality Assurance Compliance Specialist plays a key role in maintaining and improving the company’s Quality Management System (QMS) and ensuring ongoing compliance with regulatory requirements, including 21 CFR 111, internal quality policies, FDA expectations, and external UL GMP certification standards. This position supports cross‑functional teams, contributes to continuous improvement initiatives, and helps uphold the company’s commitment to product quality, safety, and regulatory integrity.
Specif Job duties
Support Customer Service, complaint handling activities by managing complaint intake, maintaining the complaint log, and conducting thorough adverse event reviews, investigations, and documentation. Generate and track CAPAs as needed.
Work closely with R&D to perform detailed label reviews, formulation overage updates ensuring alignment with MMR and FDA regulations, industry standards, and internal policies.
Work closely with Purchasing to carry out Foreign Supplier Verification (FSVP) verification activities, including supplier documentation review, compliance HACCP assessments, and ongoing monitoring to ensure adherence to FDA requirements
Assist with HACCP development and ongoing program maintenance, including hazard analysis updates, documentation control, verification activities, training and continuous improvement of food safety processes
Assist during FDA inspections by coordinating timely record retrieval, supporting investigator requests, and contributing to the effective closure of any FDA observations.
Develop, track, and report quality and compliance metrics as assigned by the Compliance Supervisor.
Support annual UL GMP certification activities, including preparation, documentation, and audit readiness.
Conduct internal compliance audits and follow up on corrective and preventive actions.
Develop compliance training content and deliver companywide training on GMP, process improvements, and quality system requirements.
Actively participate in QMS processes including SOP creating, Internal Audits, CAPA, Calibration, Training, and Document Control.
Work with Production and QC teams to identify, correct, and prevent compliance‑impacting deficiencies.
Analyze quality data, identify trends, and support implementation of effective corrective actions.
Serve as a team member, project lead, or project manager on company initiatives related to quality and compliance.
Perform other responsibilities as assigned by management.
Qualifications
Associates Degree preferred
2 years in QA/QC experience in an ISO or GMP environment
Strong attention to detail, excellent writing (technical/investigation) and verbal communication skills.
Excellent computer skills and working knowledge of Excel, Word and Outlook Email.
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Role Description The Quality Assurance Compliance Specialist plays a key role in maintaining and improving the company’s Quality Management System (QMS) and ensuring ongoing compliance with regulatory requirements, including 21 CFR 111, internal quality policies, FDA expectations, and external UL GMP certification standards. This position supports cross‑functional teams, contributes to continuous improvement initiatives, and helps uphold the company’s commitment to product quality, safety, and regulatory integrity.
Specif Job duties
Support Customer Service, complaint handling activities by managing complaint intake, maintaining the complaint log, and conducting thorough adverse event reviews, investigations, and documentation. Generate and track CAPAs as needed.
Work closely with R&D to perform detailed label reviews, formulation overage updates ensuring alignment with MMR and FDA regulations, industry standards, and internal policies.
Work closely with Purchasing to carry out Foreign Supplier Verification (FSVP) verification activities, including supplier documentation review, compliance HACCP assessments, and ongoing monitoring to ensure adherence to FDA requirements
Assist with HACCP development and ongoing program maintenance, including hazard analysis updates, documentation control, verification activities, training and continuous improvement of food safety processes
Assist during FDA inspections by coordinating timely record retrieval, supporting investigator requests, and contributing to the effective closure of any FDA observations.
Develop, track, and report quality and compliance metrics as assigned by the Compliance Supervisor.
Support annual UL GMP certification activities, including preparation, documentation, and audit readiness.
Conduct internal compliance audits and follow up on corrective and preventive actions.
Develop compliance training content and deliver companywide training on GMP, process improvements, and quality system requirements.
Actively participate in QMS processes including SOP creating, Internal Audits, CAPA, Calibration, Training, and Document Control.
Work with Production and QC teams to identify, correct, and prevent compliance‑impacting deficiencies.
Analyze quality data, identify trends, and support implementation of effective corrective actions.
Serve as a team member, project lead, or project manager on company initiatives related to quality and compliance.
Perform other responsibilities as assigned by management.
Qualifications
Associates Degree preferred
2 years in QA/QC experience in an ISO or GMP environment
Strong attention to detail, excellent writing (technical/investigation) and verbal communication skills.
Excellent computer skills and working knowledge of Excel, Word and Outlook Email.
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