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Controlled Substances Manager Job
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| Employer Name: Confidential |
SpiderID: 2470556 |
| Location: Miami Beach, Florida |
Date Posted: 9/4/2008 |
| Wage: |
Category: Biotech |
| Job Code: 3126 |
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Job Description:
Our client is a publicly traded biopharmaceutical company that is dedicated to the development and commercialization of drug delivery therapies. The company has marketed products, an experienced management team and an empowering corporate culture that is focused on the professional development of its employees. This is a great opportunity for the right candidate.
Job Responsibilities:
1) Establish corporate policies and procedures
2) Manage systems for compliance with DEA regulations regarding controlled substances
3) Serve as host for DEA regulatory inspections
4) Generate and manage DEA-related documentation required for filing with Federal regulatory bodies
5) Handle ARCOS reporting as well as DEA quota documentation and submission
6) Manage all internal and external controlled substance and chemical transactions to ensure compliance with appropriate regulatory requirements
7) Create biennial and annual inventory
8) Manage the investigation and documentation of controlled substance variances, loss, theft and any other DEA reportable incidences and notify DEA
9) Oversee compliance with all operating functions of controlled substance inventory (receipt and distribution, product recall, return goods, compliance and operational deviations/investigations and SOP administration)
10) Manage controlled substance waste pending destruction process internally
11) Coordinate activities with DEA or a certified controlled substance destruction company
12) Assist in establishing and training on controlled substance transportation procedures to comply with DOT training requirements
13) Regulate operating functions regarding controlled substance security oversight, federal controlled substance licenses and inspection by local DEA offices
14) Train employees on DEA regulations regarding the controlling and handling of controlled substances and related chemicals (as required)
15) Manage the controlled substances within the Operations/Materials Management Departments
16) Handle the storage, inventory, destruction, relation reports and reconciliation of controlled substances as per DEA and company policies
17) Provide advice and guidance to departmental staff, other Manufacturing Operations and R&D Team members in the DEA regulations as well as communicate facility DEA activities and reports
18) Work on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors
19) Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
20) Develop and administer budgets, schedules and performance requirements
21) Interact with senior management for matters between functional areas, other company divisions or units, customers and DEA
22) Act as Advisor to subordinate(s) to meet schedules and/or resolve technical problems
23) Manage (through subordinate supervisors) the coordination of the activities of a section(s) or department(s) with duties for results in terms of costs, methods and employees
Job Requirements:
1) BS in Chemistry or a related discipline
2) Minimum 5 – 8 years of professional experience in pharmaceutical QA or materials management environment
3) Good working knowledge of CFR and state regulations (as they apply to cGMPs and DEA)
4) Knowledge of federal and state regulatory agencies
5) Excellent interpersonal and organizational skills
6) Superb communication skills in English (oral and written)
7) Leadership skills with ability to motivate others
8) Hands-on computer skills with expertise in MS Office including Excel and Power Point (statistics, graphing, presentations, etc.)
Applicants are encouraged to apply directly by going to: http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-03126.html
Job Criteria:
Start Date: ASAP
Position Type: Full-Time Permanent
Years of Experience Required: 5
Education Required: Bachelors
Overnight Travel:
Vacation Time:
Company Profile:
Our Life Sciences practice provides executive search and recruitment services to pharmaceuticals, medical devices, and biotech industries. We represent venture capital firms and their portfolio life science and contract research companies in matters of executive search and corporate development.
Contact Information:
| Contact Name: Jennifer Huston |
Company Type: Recruiter |
| Company: Sterling-Hoffman Life Sciences |
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| City: Toronto |
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| State: Ontario |
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| Zip: M5G 1T6 |
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Web Site: http://www.sterlinglifesciences.com/
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