Qa Specialist-Dea

Experienced professional who assists and supports the organization to ensure compliance to Federal, state and local requirements for controlled substances (DEA). Responsible to implement, manage, and maintain Corporate DEA Compliance Program and collaborate to determine the overall DEA Compliance Strategy. Additionally, supports initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing. Alternatively, conducts internal production/process and manufacturing quality control audits and risk assessments. Role may be in Compliance, Lot Review or Audit/Inspection.

Key Accountabilities:
" Monitor all state and federal licensing requirements regarding the handling of controlled material
" Oversee the applications for procurement quota; Monitor the use of DEA 222 order forms for compliance with DEA requirements
" Responsibility for maintaining evolving Suspicious Order Monitoring Program and strategy while maintaining regulatory compliance and lead enhancement development
" Escalate and notify management and responsible agency in event of theft/diversion of controlled substances. Includes investigation into allegation of non-compliance or non-conformance reports
" Manage controlled substance inventory and monitor all associated activities to include periodic reporting (ARCOS and YERS reporting)
" Performs document reviews of SOP's, batch records, test methods, and logbooks to ensure cGMP activities are completed and documented in accordance with approved, written procedures. May also review raw materials, work orders, validation and MSAT reports.
" Independently writes/approves SOPs, Master Batch Records, customer audit and regulatory CAPA as pertaining to controlled substance activity.
" Works with technical transfer teams to prepare new processes; act as responsible QA designee.
" May participate in investigations into minor and major root cause, corrective or preventive actions and impact to product safety, identity, strength, quality or purity.

" Leads audits, and tracks audit and inspection commitments.
" Serve as liaison to the DEA.

" Creates and presents training seminars on compliance issues including DEA requirements for job role.
" Owns and leads special projects, often complex in nature.
" Ensure Compliance with DEA Import/Export Regulation
" Serve as Principle Consultant on the security design of all construction and renovation initiatives related, and not limited to all controlled substance manufacturing, packaging/labeling and storage.
" Ensure proper security controls are in place for shipping and receiving controlled drugs
" Coordination of controlled drugs destructions in accordance with DEA regulations
" Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear
" Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible
" Stop work where deemed necessary to maintain safety
Minimum Years Required Experience:

Key Requirements:

Minimum Education Level Required: Bachelors

Preferred Field of Study: Science

5

Preferred Field of Experience: Pharma cGMP