Senior Quality Compliance Analyst

LifeCell develops and markets tissue repair products for use in reconstructive, urogynecologic and orthopedic surgical procedures. LifeCells current marketed products include: Strattice? Reconstructive Tissue Matrix and AlloDerm® Regenerative Tissue Matrix, for plastic, reconstructive, general surgical, burn and periodontal procedures; Cymetra® Regenerative Tissue Matrix, a particulate form of AlloDerm® Tissue Matrix suitable for injection; Repliform® Regenerative Tissue Matrix, for urogynecologic surgical procedures; GraftJacket®, for orthopedic surgical procedures; and AlloCraft• DBM, for bone grafting procedures.

The Sr Quality Compliance Analyst facilitates & coordinates the LifeCell Compliance Tissue Recovery Organization (TRO) audit process.  This includes scheduling the annual audits, performing and/or ensuring the performance of the required audits, performing effectiveness checks for previous CAPAs where applicable, preparing the audit 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.  This also includes ensuring the TRO Master List is maintained which is used to determine audit performance.

Performs analysis of Tissue Recovery Organization data which includes ensuring quarterly performance monitoring is completed and improvement plans are identified, performed, and effective.

Ensure Tissue Recovery Partners are informed of changes in LifeCell specifications as well as current and proposed standards and regulations of regulatory & state agencies.

Provides support to the Compliance Team by working to ensure Tissue Recovery Partner compliance with AATB Standards and Federal and State regulations.  Ensures LifeCells AATB Accreditation by reviewing standards updates and reporting these requirements to the appropriate departments of LifeCell and ensuring implementation. Participating in at least 1 AATB Task Force representing LifeCell as part of AATB initiatives and updates.  Ensure that all reporting requirements to the AATB are met and attend at a minimum 1 AATB meeting per year.  Ensures LifeCell compliance with Federal and State regulations and AATB Standards. Works collaboratively with all teams of LifeCell to identify compliance needs and integrate accordingly.

Perform quarterly management data for management review.  This includes compliance metrics including audits, recalls, external inspections of LifeCell and supplier corrective actions.

Coordinates LifeCell Compliance to external inspections performed of LifeCell. This includes ensuring adequate resources are available to support third party inspections, facilitating the inspections, working with QA ensuring Quality Investigations of external inspections findings are initiated, ensuring that audit findings are appropriately addressed through corrective and/or preventative actions within agreed upon timeframes, and ensures all audit 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.  Ensures appropriate Quality Investigations, root cause analysis and corrective actions are identified and implemented as required / needed.

Performs the effectiveness checks 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, facilities, marketing, etc. to ensure compliance with LifeCell and Regulatory Requirements.

PRINCIPAL RESPONSIBILITIES:

1.      Coordinate LifeCells Tissue Recovery Organziation audit process. Responsible for generating the Tissue Recovery Organization annual audit schedule, ensuring audits are performed on schedule, ensuring the implementation of agreed upon corrective and preventative actions and ensure audit closure.

2.      Compile and contribute audit metrics. Establish and maintain quality metrics for TRP, internal and supplier audits.

3.      Monitor TRP performance. Work with Tissue Services personnel to verify and report on recovery partner performance, error and discrepancy rates, as well as failure rates for micro failures, MD failures, and serology failures.

4.      Act as liaison between Tissue Recovery Partners and LifeCell. Work with Tissue Services Representatives and Regional Managers to identify corrective/preventative action plans in response to audit findings and ensure the completion of audit responses.

5.      Ensure compliance with regulatory bodies and states. Work to ensure that LifeCell maintains up-to-date policies and procedures, and operations are conducted in accordance with applicable International, Federal, and State regulations.

6.      Assist in oversight of CAPA system. This includes reviewing CAPA documentation for accuracy and completeness and reviewing for effectiveness of CAPA actions performed.

7.      Work collaboratively within LifeCell. Work with teams from manufacturing, finance, marketing, facilities, quality, etc. to ensure audit responses to Internal and Regulatory findings are addressed and compliance to LifeCell and Regulatory Requirements.

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, and prepare & maintain reports.

A Bachelors degree in the physical or life sciences or equivalent experience is required.  Must be a Certified Tissue Bank Specialist (CTBS) or obtain certification within 2 years. Professional auditing certification by ASQ or similar body is preferred.

A minimum of 3 to 5 years in a Quality Systems environment. Minimum 2 years of relevant experience in compiling data, producing metrics and graphics, and analyzing aforementioned data for pertinent trends required.

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.

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 TRP audits & continuing education.

Willing to work variable hours, including weekends and nights, as required. Some on-call for off-hour support may be required.

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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