*Quality Compliance Supplier Specialist

*Quality Compliance Supplier Specialist Mar 19, 2009 Branchburg, New Jersey  Return to Search Results|Send job to a friend  Description:  JOB SUMMARY/PURPOSE:

Provide support to LifeCell’s Supplier Evaluation Program.  This includes reviewing supplier request forms, assessing the level of supplier evaluation required, ensuring that all supplier evaluation criteria is maintained and is current as applicable including but not limited to supplier on-site audits, the completion of surveys and reports, and obtaining current qualifying certifications. The Compliance Specialist shall review all completed surveys and certifications/CVs as applicable for acceptability and make a determination for supplier approval. The Compliance Specialist shall work with the Senior Quality Compliance Auditor to ensure that an annual supplier on-site audit schedule is generated, maintained, and documented accordingly. Provides support to the Senior Quality Compliance Auditor to develop on-site audit plans, develop audit critieria, performing and/or ensuring the performance of the required audits, performing effectiveness checks for previous CAPAs where applicable, preparing the audit plan/report, sending the audit report to the auditee, ensuring that audit findings are appropriately addressed through corrective and/or preventative actions within agreed upon timeframes, and closing the audits.  The Compliance Specialist is responsible for reviewing all CAPA plans and CAPA suitability to ensure that root cause has been addressed.

Reviews the actions performed associated with supplier/vendor nonconformances, deviations, and Quality Investigations and initiate supplier investigation reports where applicable ensuring supplier corrective and preventative actions are taken as needed.

Maintains the Supplier Master file ensuring that all supplier files remain current.

Maintains data for quarterly management review which includes reporting on supplier performance.

Provides support to the Compliance Team by working to ensure supplier compliance with all applicable regulations.

Supports external inspections performed of LifeCell as needed. This includes ensuring adequate resources are available to support/host outside inspections, facilitating the inspections, working with the QA group to ensure Quality Investigations are initiated for inspection findings as applicable, ensuring that audit findings are appropriately addressed through corrective and/or preventative actions within agreed upon timeframes, and ensure all inspection follow-up activity is coordinated / performed. 

Provides Recall support to the Compliance Team by coordinating Recall team meetings as needed. This includes identifying appropriate team members, coordinating all required actions and follow up / correspondence with Tissue Recovery Partners, Distribution Partners, AATB, State, and all Regulatory Agencies. Works with the QA group ensuring appropriate Quality Investigations, root cause analysis and corrective actions are identified, implemented, and documented as required / needed.

Performs follow-up on LifeCell corrective and preventative actions (CAPA) and ensures effectiveness of CAPA actions associated with Quality Investigations (QI).

Works collaboratively with teams from manufacturing, quality, regulatory, finance, and marketing as necessary.

PRINCIPAL RESPONSIBILITIES: 1.  Provide support to LifeCell’s Supplier Evaluation Program. Work with the Sr. Quality Compliance Auditor reviewing supplier request forms, generating audit schedules, preparing audit plans, performing/facilitating supplier on-site audits, ensuring audit closure with the implementation of agreed upon corrective and preventative actions. Monitor and analyze effectiveness of corrective and preventative actions implemented as a result of compliance audits. Follow up to ensure that all corrective actions are closed within agreed-upon timeframes. 2.  Compile and contribute audit metrics.Establish and maintain quality metrics of supplier performance. 3.  Monitor Supplier performance.Review supplier/vendor nonconformances, deviations, and quality investigations ensuring appropriate corrective and preventive action is taken to address the root cause.  4.  Ensure compliance with regulatory bodies and states.Work to ensure that LifeCell supplier quality meets all applicable International, Federal, and State regulations. 5.  Assist in oversight of CAPA system.This includes reviewing CAPA documentation for accuracy and completeness and reviewing for effectiveness of CAPA actions performed. 6.  Supports LifeCell Compliance to External Inspections. Work with compliance group ensuring adequate preparation and resources are available to support/host outside inspections. Work with the QA group to ensure Quality Investigations are initiated for inspection findings and ensure that findings are appropriately addressed through corrective and preventive actions. Work with the compliance group to ensure all inspection follow-up activity is performed. 7.  Work collaboratively within LifeCell.Work with teams from manufacturing, finance, marketing, regulatory and quality to ensure supplier compliance and that audit responses to Regulatory findings are addressed. 8.  Support the Quality Compliance Team.Contribute to the overall optimization of the Compliance team. Assist in the day-to-day departmental activity, including generating and revising procedures, forms, specifications, work instructions as needed, establishing and maintaining files for the team, arrange audit travel plans and itinerary, monitor and maintain various spreadsheets, organize meetings, meeting minutes, interfaces with customer contacts as required, and prepare & maintain reports.

QUALIFICATIONS:

MINIMUM EDUCATION: B.A. /B.S. degree – technical (physical or life sciences) or equivalent experience. Professional auditing certification by ASQ or similar body is preferred.

MINIMUM SKILLS AND EXPERIENCE: 3 to 5 years in a Quality Systems/auditing environment. Experience with multiple quality software programs: MS Excel and electronic data management systems (EDMS). Excellent interpersonal skills required. Must be self-motivated, organized, and able to work independently.

PREFERRED EDUCATION: B.A. /B.S. degree – technical (physical or life sciences) or equivalent experience.

PREFERRED SKILLS AND EXPERIENCE: Professional auditing certification by ASQ or similar body is preferred.

TRAVEL REQUIREMENTS: Approximately 20% travel

PHYSICAL REQUIREMENTS: Ability to carry and lift boxes weighing not more than 20 lbs.Normalspeech, hearing and vision. Must be able to drive a car and travel in commercial/chartered aircraft. Must be able to lift, move, or carry IT hardware as necessary.

WORKING ENVIRONMENT: Majority of work performed in an office setting; some laboratory possible. Must be willing to travel, as necessary, to assist in the performance and follow-up of supplier audits & continuing education. Willing to work variable hours, including weekends and nights, as required. Some on-call for off-hour support as required.

COMMUNICATION SKILLS: Ability to communicate effectively, both verbally and written, with all levels of diverse cultures.

POSITIONS SUPERVISED:

CUSTOMERS: External – Suppliers, regulatory/accreditation bodies/agencies Internal - RA/QA, QC, Documentation, Finance, Customer Support, Manufacturing, and Marketing

Please refer to job code lifecell-542731 when responding to this ad.

Category:	Accounting/Banking/Finance/Insurance
	> Other Banking
Location:	Branchburg, NJ
County:	County
ZIP Code:
Pay Rate:	Open
Job Terms:	full time
Company:	LifeCell
Phone:	email only please
Fax:	email only please