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Senior QA Compliance Associate, DEA - Cranbury NJ

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Taro in USA
 
JOB TITLE: Senior QA Compliance Associate, DEA
DEPARTMENT: Quality Assurance Compliance
REPORTS TO: Manager, DEA & QA Operations
DIRECT REPORTS: None
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GENERAL SUMMARY:
This position provides Quality Assurance support in DEA & overall Compliance for continuous process improvement; manages and promotes the closure of Investigations, Nonconformance, CAPA, eKA, Change Control, Internal and External Audits; and develops, implements and maintains SOP’s, and creates or revises documents as required.
 
RESPONSIBILITIES:
1. Ensure 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. Updates and reviews standard operating procedures, work instructions, forms and templates as required by management. Draft, edit and approve local department procedures in eKA system. Reviews and revises SOPs to align site quality needs with TARO Corporate Quality standards
3. Review cycle count audits of finished goods inventory, investigate inventory discrepancies and in-transit losses, and report findings to the DEA as necessary.
4. Manage, prepare and submit periodic reports for the DEA including ARCOS Reporting and Year End Reports (YERS)
5. Oversee annual procurement quota and submit for additional quota if required
6. Provide support with DEA audits both internally and externally to ensure that established procedures are being followed and documented, required reports are being filed, and inventories are reconciled.
7. Oversees and monitor the open nonconformance’s to ensure all activities 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. Serve as subject matter expert within functional areas.
8. Provide training and guidance on the nonconformance system, problem statements, investigations and root cause analysis.
9. Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, DEA, EMA, EPA and OSHA. Complies with all company policies, standards and procedures.
10. Successfully completes regulatory and job training requirements. Remains current in skills and maintain industry trends.
11. Compiles a monthly report on nonconformance’s, CAPA and other quality matrix for site quality council that shall be escalated for review to management. Be responsible for providing individual or customized reports to any department or management.
12. Provide reports and documentation to the FDA, internal audit or any other auditing body. Conducts internal quality audits and coordinates external inspections when required. To facilitates Regulatory Inspection activities and responses.
13. Coordinates, maintains and approves site Quality Risk Assessments. Coordinates, maintains, reports and drives Quality System metrics.
14. Develops and maintains inspection readiness systems at NJDC site.
15. Acts as SME for Quality-focused systems/projects. Provides training for Quality concepts or systems including annual GMP training.
16. Monitors non-conformance and action data for trends. Proactively identifies, evaluates, and facilitates remediation of compliance risks.
17. Provides Quality/Compliance guidance and recommendations to site personnel for investigations, change controls, protocols, reports, area releases, project planning and site procedures.
18. Participate in change control as owner, assessor or approver. You may provide document management processing and oversight
19. Participate in Investigations as owner, reviewer, process owner, or Quality approver.
20. Participate in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes.
21. Review validation protocols and reports, equipment/facility change requests, calibration documentation for any new change control request.
22. Resolve complex issues using business and root cause identification and remediation tools.
23. Act as a trainer and SME for new people in the organization.
24. Maintains and manages monthly reports needed to ensure high quality, real-time compliance practices.
25. Perform other duties as assigned & providing overtime as needed.
 
KNOWLEDGE, SKILLS/ABILITIES & EXPERIENCE TO DO THE JOB:
1. B S. /B.A. Degree in a scientific discipline or equivalent experience.
2. Knowledge of regulations for DEA, GMP, ICH and FDA guidelines.
3. Must have 8 years quality compliance experience in the pharmaceutical industry.
4. Proficiency in Microsoft Excel, Word, and Lotus Notes.
5. Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up, excellent communication and writing skills.
 
WORKING CONDITIONS:
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.
 
DISCLAIMER:
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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