Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Fluctuating Temps hot/cold
Job Description
Summary:
As a Control Substance Program Coordinator at Thermo Fisher Scientific, you'll apply your expertise to ensure compliance in healthcare.
Essential Functions:
- Strictly ensure compliance with Title 21 Code of Federal Regulations (Part 1300 to End) and corporate standard operating procedures for controlled substances.
- Successfully implement and maintain records and reports including DEA-222 Forms, ARCOS, Biennial Inventories, Quota Submissions, and Year End Reports.
- Determine and monitor regulatory changes by maintaining up-to-date knowledge of the Code of Federal Regulations.
- Collaborate with management on DEA inspections, internal audits, and corrective actions.
- Coordinate the flawless receipt, storage, dispensing, shipment, and record keeping of controlled substances.
- Facilitate all Import/Export applications, declarations, permits, and shipments.
- Build, update, and educate employees on Standard Operating Procedures and DEA regulations.
- Coordinate the collection, labeling, storage, security, transportation, and destruction of controlled substance waste.
Quality Specific Tasks:
- Act as a subject matter expert during FDA inspections, Notified Body, customer audits, and other third-party evaluations.
- Author and update SOPs to ensure compliance with QMS and regulatory requirements.
- Support Change Control processes and participate in internal audits.
- Investigate and resolve deviations, non-conformances, and quality issues.
- Manage multiple projects from start to finish with minimal supervision, ensuring compliance timelines are met.
Education:
- Minimum Bachelor’s (required) in Chemistry, Biology, Microbiology or a related field is preferred.
Experience:
- Proven experience in DEA Compliance within Pharmaceutical Manufacturing.
- Experience in GMP Quality Assurance.
- Experience in Product Development is preferred.
Proficiencies:
Required:
- Knowledge of Good Manufacturing Practices (GMP) and experience in a regulated manufacturing environment.
- Strong writing, interpersonal, and verbal communication skills.
- Outstanding organizational and analytical skills with attention to detail.
- Proficiency in Microsoft Office applications.
Preferred:
- Master's degree in a related field or equivalent experience.
- Knowledge of DEA compliance regulations and experience in DEA compliance.
- Experience with QMS, document control, and regulatory audits.
Physical Requirements:
Role involves walking, standing, bending, and lifting items; using hands and fingers for typing; visual acuity for computer work; sitting, reaching, talking, and hearing.
Disclaimer:
This job description aims to outline the overall content and requirements for carrying out this job. The description should not be interpreted as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign additional tasks as necessary.
Language here intends to align with each country's legislation, including the EU Equality Directive.
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