QA Supplier Quality Auditor
Company Name:
NeoStem/PCT
QA Associate III / Supplier Quality Auditor (IMMEDIATE OPENING!!!)
We are seeking a highly motivated QA Associate III / Supplier Quality Auditor who is interested in joining our fast-paced, dynamic environment.
This position performs audit external vendors/suppliers; maintain approved supplier list; qualify and approve supplier/vendors; support Quality teams for improvements associated to auditing and quality systems. This position includes Quality Assurance activities with minimal if any supervision of daily tasks in support of PCT's Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases. The ideal candidate for this position also assists Quality management with department needs. This position is based in Allendale, NJ.
Responsibilities:
Audit external vendors/suppliers; maintain approved supplier list; qualify and approve supplier/vendors; support Quality teams for improvements associated to auditing and quality systems.
Ensures the safe release of cellular products in accordance with PCT and/or client procedures and requirements.
Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs
Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues.
Author and review relevant SOPs, validation and other documents.
Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports.
Responsible for the completion of all client requirements related to cellular product and/or material releases.
Master Batch Record Control, distribution and label verification
Perform line clearance activities as required.
Assignment and maintenance of product Lot numbers as applicable.
Perform internal documentation audits as assigned.
Materials management nonconformance disposition and release activity as applicable.
Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures
Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions.
Track and trend relevant quality metrics including environmental monitoring data.
Provide Quality Assurance related support to various departments.
Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.
Electronic Document Control activities as assigned.
Provide training to personnel as assigned by supervisor.
Travel may be required.
Education and
Experience:
Bachelor's Degree in biological sciences or a relevant field required
Minimum of 5-8 years related experience in the pharmaceutical or biologics industry WITH Supplier Auditing experience required
Strong understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs) required
Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc. preferred
Applicable or related experience in a clinical laboratory, hematology, blood banking, immunology or QA laboratory preferably in a CGMP/GTP environment
Sound knowledge of aseptic processing and supporting technologies
Analytical and technical trouble-shooting skills are a plus
Strong team-oriented, interpersonal skills are essential
Excellent organizational skills and attention to detail
Good verbal and written communication skills
About Us
PCT, a Caladrius company is among the first of a new breed of immunotherapy companies with proven expertise and unique experience in cell process optimization, development, and manufacturing. Caladrius is a cell therapy leader with late-stage clinical programs based on a proprietary platform technology for immuno-oncology, as well as additional platform technologies for ischemic repair and immunomodulation, and capabilities that support other cell therapy developers. This integrated approach supports the industry in bringing significant life-improving medical treatments to market.
We challenge our employees to become leaders in the emerging field of cellular therapy. It takes a team of experts to help us lead the paradigm shift in medicine-- a shift away from just treating symptoms and towards finding cures for chronic disease and illness.
Connect with us on LinkedIn at http://www.linkedin.com/in/pctcelltherapy
Follow us on Twitter @PCTcelltherapy
If you are interested in this exciting opportunity, please send a copy of your CV or Resume directly toEstimated Salary: $20 to $28 per hour based on qualifications.
NeoStem/PCT
QA Associate III / Supplier Quality Auditor (IMMEDIATE OPENING!!!)
We are seeking a highly motivated QA Associate III / Supplier Quality Auditor who is interested in joining our fast-paced, dynamic environment.
This position performs audit external vendors/suppliers; maintain approved supplier list; qualify and approve supplier/vendors; support Quality teams for improvements associated to auditing and quality systems. This position includes Quality Assurance activities with minimal if any supervision of daily tasks in support of PCT's Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases. The ideal candidate for this position also assists Quality management with department needs. This position is based in Allendale, NJ.
Responsibilities:
Audit external vendors/suppliers; maintain approved supplier list; qualify and approve supplier/vendors; support Quality teams for improvements associated to auditing and quality systems.
Ensures the safe release of cellular products in accordance with PCT and/or client procedures and requirements.
Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs
Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues.
Author and review relevant SOPs, validation and other documents.
Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports.
Responsible for the completion of all client requirements related to cellular product and/or material releases.
Master Batch Record Control, distribution and label verification
Perform line clearance activities as required.
Assignment and maintenance of product Lot numbers as applicable.
Perform internal documentation audits as assigned.
Materials management nonconformance disposition and release activity as applicable.
Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures
Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions.
Track and trend relevant quality metrics including environmental monitoring data.
Provide Quality Assurance related support to various departments.
Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.
Electronic Document Control activities as assigned.
Provide training to personnel as assigned by supervisor.
Travel may be required.
Education and
Experience:
Bachelor's Degree in biological sciences or a relevant field required
Minimum of 5-8 years related experience in the pharmaceutical or biologics industry WITH Supplier Auditing experience required
Strong understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs) required
Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc. preferred
Applicable or related experience in a clinical laboratory, hematology, blood banking, immunology or QA laboratory preferably in a CGMP/GTP environment
Sound knowledge of aseptic processing and supporting technologies
Analytical and technical trouble-shooting skills are a plus
Strong team-oriented, interpersonal skills are essential
Excellent organizational skills and attention to detail
Good verbal and written communication skills
About Us
PCT, a Caladrius company is among the first of a new breed of immunotherapy companies with proven expertise and unique experience in cell process optimization, development, and manufacturing. Caladrius is a cell therapy leader with late-stage clinical programs based on a proprietary platform technology for immuno-oncology, as well as additional platform technologies for ischemic repair and immunomodulation, and capabilities that support other cell therapy developers. This integrated approach supports the industry in bringing significant life-improving medical treatments to market.
We challenge our employees to become leaders in the emerging field of cellular therapy. It takes a team of experts to help us lead the paradigm shift in medicine-- a shift away from just treating symptoms and towards finding cures for chronic disease and illness.
Connect with us on LinkedIn at http://www.linkedin.com/in/pctcelltherapy
Follow us on Twitter @PCTcelltherapy
If you are interested in this exciting opportunity, please send a copy of your CV or Resume directly toEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
