Apothékary
Food & Beverage
QualityandComplianceSpecialist
“Quality and Compliance Specialist at Apothékary. Skills: Quality management systems, Regulatory compliance, CGMP requirements, SOP development. Support quality systems development. Organize quality systems documentation”
Industry & Context.
Root cause analysis; Problem-solving
On-site quality checks
What They're Looking For.
Must Have
3-5 years experience, Dietary supplement quality systems experience, CGMP compliance experience, Raw material qualification experience, Batch record review experience, Stability testing experience, Product documentation experience, Background in nutrition, Background in food science, Background in biology, Background in chemistry, Excellent verbal communication skills, Excellent written communication skills, Excellent time management skills, Analytical skills, Problem-solving skills, Proficient with Microsoft Office, Proficient with Google Suite
Nice to Have
Foundation in dietary supplement regulations, Foundation in quality systems, Meticulous attention to detail
What You'll Do.
Support quality systems development
Organize quality systems documentation
Manage QA documentation
Manage product quality issues
Investigate out-of-spec results
Perform root cause analysis
Recommend remediation
Lead stability testing programs
Design stability protocols
Manage stability samples
Report stability results
Serve as audit contact
Coordinate audit documentation
Manage co-manufacturer communication
Ensure quality standards adherence
Resolve documentation issues
Resolve quality issues
Support co-manufacturer onboarding
Establish quality parameters
Establish documentation requirements
Conduct product quality evaluations
Inspect finished goods
Perform packaging quality checks
Perform labeling quality checks
Support on-site quality checks
Support final product review
Support release decisions
Manage certification strategy
Manage certification applications
Ensure timely renewals
Expand into new certifications
Serve as liaison with certification bodies
Serve as liaison with auditors
Coordinate annual audits
Coordinate surveillance audits
Coordinate recertification activities
Monitor regulatory changes
Implement necessary updates
Manage certified product lists
Ensure accurate certification claims
Support labeling review
Support marketing materials review
Monitor federal regulations
Monitor state regulations
Monitor international regulations
Support product registration
Support product notification
Develop compliant product claims
Prepare retailer documentation
Submit retailer documentation
Maintain adverse event reporting systems
Ensure timely report submission
Coordinate responses to inquiries
Support preparation of warning letter responses
Support regulatory submissions
Develop quality training programs
Develop compliance training programs
Deliver quality training
Deliver compliance training
Maintain training records
Ensure personnel qualification
Foster quality culture
Serve as quality resource
Serve as regulatory resource
Escalate complex issues
How You'll Work.
Team & Collaboration
Cross-functional collaboration; Co-manufacturer communication; Internal stakeholders collaboration; Creative leadership collaboration; Regulatory leadership collaboration
Communication Scope
Verbal communication; Written communication; Compliant content review
Process & Methodology
CAPA management
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