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Senior Associate, DEA - Cranbury NJ

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Taro in USA
JOB TITLE: Senior Associate, DEA
DEPARTMENT: Quality Assurance Compliance
REPORTS TO: NJDC Manager, DEA & QA Operations
This position provides Quality Assurance support in DEA & associated Compliance for continuous process improvement; related to controlled drug substances requirements.
1. Ensure all DEA compliance and regulatory standard operating procedure (SOP's) guidelines are being followed. Monitor the use of DEA222 order forms and electronic forms (CSOS) for compliance with DEA requirements. Assist with the development and revision of procedures to ensure accurate documentation, traceability, and accountability as it relates to controlled dangerous substances (CDS) to minimize the risk of diversion.
2. Review, all Suspicious Order Monitoring (SOMs) reports daily and maintains appropriate records.
3. Manage, prepare and submit periodic reports for the DEA including ARCOS Reporting and Year End Reports (YERS), State Reports and maintain appropriate records as per TARO/DEA, State regulations.
4. Updates and reviews standard operating procedures in DEA area, workinstructions, forms and templates as in eKA system. Reviews and revises SOPs toalign site quality needs with DEA regulations to meet TARO corporate standard whenrelated to DAE operations and industry standard.
5. Review cycle count audits of finished goods inventory, and inventories arereconciled. Investigate inventory discrepanciesand in-transit losses, shortage and report findings to the DEA as necessary. Maintain all trackers in QA drive.
6. Oversee annual procurement quota and submit for additional quota if required with all stakeholders. Work with stakeholders on permits approval, communicates with all parties when required.
7. Provide support for DEA audits both internally and externally to ensure that established procedures are being followed and documented, required reports are being filed.
8. Oversees and monitor all DEA related nonconformance’s to ensure allactivities are being completed in a timely manner. Complete an independent review of the nonconformance deviation to assess for level, trend and assign action items as necessary.
9. Provide training and guidance on the nonconformance system, problemstatements, investigations and root cause analysis for all controlled substancesrelated investigations.
10. Carries out duties in compliance with all local, state and federal regulations and guidelines including DEA, FDA, EMA, EPA and OSHA. Complies with all company policies, standards and procedures.
11. Provide reports and documentation to the DEA, internal audit or any otherauditing body. Conducts internal quality audits and coordinates externalinspections when required. To facilitates Regulatory Inspection activities and responses to DEA.
12. Coordinates, maintains and approves site DEA Quality Risk Assessments.Coordinates, maintains, reports and drives Quality System metrics. Develops and maintains inspection readiness systems at NJDC site.
13. Acts as DEA SME for DEA Quality-focused systems/projects. Providestraining for Quality concepts or systems including annual GMP training including DEA job specific to certified individuals at NJDC, maintain the list in QA folderin the shared drive.
14. Monitors DEA related non-conformances and data for trends. Proactivelyidentifies, evaluates, and facilitates remediation of compliance risks.
15. Participate in change control as owner, assessor or approver for DEA related changes.
16. Participate in all DEA related Investigations as owner, reviewer, processowner, or Quality approver.
17. Participate in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes.
18. Resolve complex issues using business and root cause identification andremediation tools.
19. Act as a trainer in DEA area and SME for DEA related business.
20. Maintains and manages monthly reports needed to ensure high quality, real-time compliance practices.
21. Perform other duties as assigned & providing overtime as needed.
1. B S. /B.A. Degree in a scientific discipline or equivalent experience.
2. Knowledge of regulations for DEA, GMP, and FDA guidelines.
3. Must have 8 years quality compliance experience in the pharmaceuticalindustry.
4. Proficiency in Microsoft Excel, Word, PowerPoint.
5. Strong focus on flexibility, ability to multi-task, attention to detail,excellent organizational skills, good follow-up, excellent communication and writing skills.
1. 10% travel to local sites when needed.
2. Regular hours are 8:30am to 5.00pm or 9:00am to 5:30pm, with extended hours as required resolving urgent issues.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude Taro Pharmaceuticals from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
Taro Pharmaceuticals provides equal employment opportunities for all current employees and applicants for employment. No one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, sexual orientation, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

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