| Location | Williston, VT |
The Standards Specialist supports Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), including the FDA's ALCOA++ data integrity principles, for cosmetic and OTC drug-cosmetic products manufactured by Twincraft Skincare. The role manages and verifies manufacturing records, investigations, and change controls; supports audits; and maintains accurate, current, inspection-ready records. Working across Quality, Manufacturing, R&D, and other departments, the specialist drives continuous improvement and ensures activities meet applicable procedures, regulatory requirements, customer expectations, and company standards.
Essential Duties and Responsibilities:
Maintain and support GMP documentation systems, ensuring accuracy, completeness, traceability, and compliance with regulatory standards.
Lead and support investigations of deviation, non-conformance, and out-of-specification results.
Perform root cause analysis and support development of corrective and preventive actions (CAPA) as appropriate.
Manage compliance records and workflows within ETQ (or equivalent Quality Management System (QMS) platform).
Support the creation, revision, and lifecycle management of Standard Operating Procedures (SOPs).
Support training program administration, including tracking, documentation, and coordination of GMP and compliance training.
Support internal and external audits, including preparation, documentation retrieval, and follow-up on findings.
Conduct and support laboratory investigations related to quality or compliance issues.
Identify and drive continuous improvement initiatives across quality and compliance processes.
Support change control processes, ensuring proper documentation and cross-functional review.
Maintain document management systems, ensuring version control, retention, and accessibility of controlled documents.
Identify unusual trends, non-conformances, or other potential concerns and escalate them to the appropriate personnel.
Support company adherence to policies and procedures, practices associated with held certifications and regulatory commitments.
Maintain accurate, timely, and complete documentation and data associated with assigned responsibilities.
Communicate compliance, quality, and documentation concerns promptly and objectively.
Support operational flexibility and changing business needs at Twincraft without compromising product quality, compliance, or data integrity.
Work cross functionally with all departments within Twincraft.
Support and adhere to Twincraft's policies, procedures, and values.
Perform other duties as assigned.