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.
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