Standards Specialist

The Standards Specialist supports Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) including the FDAs 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 Twincrafts policies procedures and values.
• Perform other duties as assigned.

Required Experience:

IC