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25 days old

Quality Control Manager- Cell Therapy- Permanent position

Kelly Services
Allendale, NJ 07401
**Permanent position- Manager, Quality Control- Cell Therapy**



**Bergen County, NJ 07401**





Overview:





+ The Manager, Quality Control (QC) plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production.

+ Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP (Good Tissue Practice) environment a must

+ 7 10 years experience in the pharmaceutical, biologics or related industry.

+ The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the companys facility.

+ Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of
production processes and validation

+ Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries.





Essential Functions and Responsibilities:





+ Hiring, developing, training, and evaluating QC personnel

+ Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies

+ Ensuring completion of all client QC requirements related to GMP cellular products and/or materials. Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable.

+ Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records.

+ Monitoring effectiveness of quality systems change control activities and their completion, for both, internal and client audit findings

+ Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function

+ Delegating maintenance, tracking, and trending aspects of the deviation reporting system

+ Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing

+ Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable

+ Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation

+ Delegating development, revisions, and implementation of SOP as related to QC activities

+ Participating in and tracking group budget setting and cost containment drives

+ Communicating and maintaining trust relationships with senior management, business partners, and clients

+ Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times











Qualifications:






+ BA/BS/MS in a science or relevant field required

+ Prior cGMP experience required

+ Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must

+ 7 10 years experience in the pharmaceutical, biologics or related industry

+ Proven ability to lead, coach, and motivate employees, clearly communicate job
requirements and effectively manage performance of assigned staff with a minimum of five (5) years in a management position preferred

+ Sound understanding of current Good Manufacturing Practices (cGMPs)

+ Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of
production processes and validation

+ Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred

+ Proven experience in a supervisory or managerial position.

+ Demonstrable experience in developing strategic plans based on business needs

+ Thorough knowledge of market changes and forces that influence the company





Competencies/Candidate Profile:





+ Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers

+ Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review





Working Environment:





+ While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.





Direct reports:




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








**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.

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

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Quality Control Manager- Cell Therapy- Permanent position

Kelly Services
Allendale, NJ 07401

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