Control Substance Program Coordinator
Control Substance Program Coordinator
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Salary Not Disclosed
1 Vacancy
Job Description
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/coldJob Description
Summary:
As a Control Substance Program Coordinator at Thermo Fisher Scientific youll 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 Bachelors (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:
- Masters 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 countrys legislation including the EU Equality Directive.
Required Experience:
IC
Employment Type
Full-Time
