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16 days old

Quality Assurance Manager- Cell Therapy- Permanent position

Kelly Services
Allendale, NJ 07401
**Permanent Position- Manager, Quality Assurance- Cell Therapy**



**Bergen County, NJ 07401**




Overview:





+ Responsible for performing Quality Assurance activities supporting clients 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 as well as assists Quality management with department needs.

+ Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments.

+ Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation.





Direct reports:





+ Candidate will oversee QA Associate I, II, and III roles. The QA Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.



Essential Functions and Responsibilities:





+ Ensure the safe release of cellular products in accordance with client procedures and requirements. Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs

+ Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues. Establish and maintain policy for documentation of all products and perform internal documentation audits.

+ Author and review relevant SOPs, validation and other documents.

+ Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports.

+ Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review.

+ Control Master Batch Records, distribution and label verification

+ Perform line clearance activities as required.

+ Assign and maintain product lot numbers as applicable.

+ Ensure materials management nonconformance disposition and release activity as applicable. Ensure 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.

+ Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.

+ Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks.
Provide support to manufacturing for investigations of deviations, validations, and development of specifications

+ Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements.

+ Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted.

+ Perform employee training on QSR and ISO requirements and company quality systems



Qualifications:





+ Minimum 5-10 years related experience in the pharmaceutical or biologics industry.

+ BS Degree in biological sciences or equivalent.

+ Understanding of cGMPs and GLPs.

+ Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc.

+ Sound knowledge of aseptic processing and supporting technologies.

+ Analytical and technical troubleshooting skills are a plus.

+ Travel may be required





Competencies/Candidate Profile:





+ Strong business acumen

+ Relevant IT skills (able to work with Visio, Microsoft Project and Excel)

+ Meeting management/facilitation skills/teamwork

+ Ability to multi-task is essential





Working Environment:




+ Working with all levels of internal management and staff as well as with external clients and contractors.





Other Duties:




Please note this job description is not designed to cover or contain a comprehensive listing of



activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

Categories

Posted: 2020-10-05 Expires: 2020-11-05

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Quality Assurance Manager- Cell Therapy- Permanent position

Kelly Services
Allendale, NJ 07401

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