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Quality Compliance Auditor
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:
5021745
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.
Lifecell currently has an opening for a Quality Compliance Auditor located in Branchburg, NJ.
The Quality Compliance Auditor will work to foster compliance to the LifeCell Quality Management System by conducting supplier and internal audits. Provide support, guidance, and follow-up to ensure corrective & preventative action and closure of audits. This position will perform tracking & trending of supplier metrics for management review & identify improvement plans.
PRINCIPAL RESPONSIBILITIES:
1. Maintain a thorough understanding of applicable regulations and guidelines: FDA Current Good Tissue Practices (21 CFR 1270/1271), AATB Standards for Tissue Banking, all applicable ISO standards, Quality System Regulation (21 CFR 820), LifeCell corporation policies and procedures, and other applicable regulations / standards.
2. Audit suppliers with respect to all relevant guidance, rules, regulations and requirements.
3. Conduct internal audits with respect to all relevant guidance, rules, regulations and requirements. Ensure consistency of systems/practices across product lines and their conformance to other industry practices.
4. Conduct tracking & trending of supplier performance for management review & identify corrective & preventative actions.
5. Development of internal operating procedures, ensuring the proper specifications for equipment and processes through validations and/or qualification.
6. Support external audits of LifeCell ensuring the identification of corrective action and closure within established timeframes.
QUALIFICATIONS:
MINIMUM EDUCATION:
BA or BS Degree – technical (physical or life sciences or engineering) or equivalent experience. Professional certification by ASQ or similar body is required.
Apply by eMail:do_not_reply@invalidemail.com
Job Created:
Fri Oct 02 2009 05:49:31 AM
Last Modified: Fri Nov 20 2009 06:02:06 AM
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