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Senior Quality Compliance Analyst
From:
Company: LifeCell Corporation (see all of this employer's jobs)
Phone: 9089471022
Fax: 1234567890
 Apply by eMail:do_not_reply@invalidemail.com
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Job Reference ID:
5146090
Category:
Scientific
Duration:
Fulltime, Permanent
City, ST:
Branchburg, New Jersey
Country:
United States |
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Description:
LifeCell develops and markets tissue repair products for use in reconstructive, urogynecologic and orthopedic surgical procedures. LifeCell's 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 LifeCell’s 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 LifeCell’s 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.
Apply by eMail:do_not_reply@invalidemail.com
Job Created:
Wed Oct 28 2009 07:01:57 AM
Last Modified: Sat Nov 21 2009 07:13:05 AM
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