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Senior Quality Compliance Associate, DEA - Cranbury NJ

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Taro in USA
JOB TITLE: Senior Quality Compliance Associate, DEA
DEPARTMENT: Quality Assurance Compliance
REPORTS TO: NJDC Manager, DEA & QA Operations
This position provides Quality Assurance support overall Compliance including DEA 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.
1. Develops and maintains inspection readiness systems at NJDC site.
2. Acts as SME for Quality-focused systems/projects. Provides training for Quality concepts or systems including annual GMP training including SQC and QBR meeting data.
3.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.
4.Provide training and guidance on the nonconformance system, problem statements, investigations and root cause analysis.
5.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.
6. Monitors non-conformance and action data for trends. Proactively identifies, evaluates, and facilitates remediation of compliance risks.
7. Provides Quality/Compliance guidance and recommendations to site personnel for investigations, change controls, protocols, reports, area releases, project planning and site procedures.
8.Participate in change control as owner, assessor or approver. You may provide document management processing and oversight.
9. Participate in Investigations as owner, reviewer, process owner, or Quality approver.
10. 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.
11. Ensure compliance and regulatory standard operating procedure (SOP's) guidelines are being followed.
12. 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.
13. Participate in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes.
14. Review validation protocols and reports, equipment/facility change requests, calibration documentation for any new change control request.
15.Act as a trainer and SME for new people in the organization.
16. 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.
17. Coordinates, maintains and approves site Quality Risk Assessments. Coordinates, maintains, reports and drives Quality System metrics.
18. 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.
19. 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, 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.
1. 10% travel to local sites when needed.
1. 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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