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Deviation/NCR Investigator
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:
5102208
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.
Under the direction of the Sr. Director, QC, the Deviation/NCR Investigator works with the Production, Quality, IT, Development, Materials, Planning and Engineering Departments to provide technical support for conducting and completing investigations.
PRINCIPAL RESPONSIBILITIES:
1. Works with all areas of Quality Control to conduct and resolve all NCR/devaitions that occur within the QC unit. This includes the areas of batch release, QC testing, QC receiving/inspection, histology and microbiology.
2. Works with the Quality Control unit to prioritize and resolve issues pertaining to CAPA and EC. Ensure all timelines are met with regards to quality investigations, NCR/deviations, CAPA and EC.
3. Works with Quality management to identify potential quality problems, to identify possible process efficiency improvements, and to troubleshoot quality control problems.
4. Assists in developing new documents, or in revising current documents, and helps to implement LCRs.
5. Assists with the yearly review of all Quality Control documents for accuracy and completeness. This will include regular audits of quality processes and regular interviews of quality personnel in order to ensure compliance to procedures or to identify areas for improvement.
6. Assists the Quality Control management in managing training records for the QC department, and oversees deviation/nonconformance awareness training and training for new revisions of procedures and other controlled documents.
7. Assist the QC group on implementing new quality procedures. This includes writing appropriate controlled procedures and conducting the training for these documents.
8. Works with the Materials group on supplier investigations as needed.
Works closely with the QC NCR/Deviation Engineer to compile trending reports as requested
REQUIREMENTS
A Bachelor’s degree in a scientific/technical field or equivalent experience is required. A minimum of 5-8 years experience in quality control/quality assurance is required. Previous supervisory experience in an FDA-regulated industry, preferably the medical device or tissue processing industries is a must. Must have excellent analytical skills and problem-solving experience. Attention to detail, and the ability to organize and prioritize multiple tasks and responsibilities. Technical writing experience is necessary.
Previous training experience is desirable.
Apply by eMail:do_not_reply@invalidemail.com
Job Created:
Tue Oct 20 2009 06:38:17 AM
Last Modified: Sat Nov 21 2009 06:48:59 AM
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