Engineering Resource Group logo

Quality Assurance Validation Manager

Engineering Resource Group

Mahwah, NJ

Engineering Resource Group
JOB DETAILS
JOB TYPE
full-time
LOCATION
Mahwah, NJ
POSTED
10 days ago

Description

Quality Assurance Validation Manager

Location: Mahwah NJ US 07430
Job Type: Direct
Reference Code: 20557-AB1
Compensation: 110000.00 - 125000.00 USD/YEAR
Start Date: 04/27/2021
Hours: Full Time
Required Years of Experience: 5
Required Education: BS Science or Engineering
Travel: No
Relocation: No
Job Industry: Pharmaceutical

Job Description :


  • Permanent position for a Quality Assurance Validation Manager to manage the development and implementation of QA validation activities and their continuous improvement initiatives at a biotech manufacturing facility in Northern NJ.

  • Ensure that quality standards are enforced.

  • Build, enhance, harmonize, and manage quality assurance validation across additional sites. Find solutions and coordinate change initiatives.

  • Provide leadership and direction to oversee and manage all validation activities by planning and allocating resources to ensure goals are met.

  • Work closely with quality training staff to develop training curriculum driven by compliance standards.

  • Coordinate investigations and closures of deviations with root cause analysis.

  • Ensure appropriate Corrective and Preventive Actions (CAPA) are initiated and implemented.

  • Manage end-to-end delivery of quality document assuring compliance of company's quality standards.

  • Review and approve GMP documents such as investigation reports, CAPA, validation protocols and reports, SOPs, change controls, etc.

  • Review and propose changes to quality agreements.

  • Participates in ongoing quality system improvement programs and initiatives.

  • Establish Quality Validation KPI Reporting and Continuous Improvement metrics.

  • Participate in internal audits, regulatory agencies, and client audits.

  • Provide technical information during tech transfer activities to ensure all quality requirements are met according to current industry standards.

  • Represent Quality Compliance in internal and external audits which may include interaction with regulatory health authorities and clients

  • Review and approve validation protocols, reports, investigation reports, assignment of CAPA's, SOP development and revisions.

  • Develop and revise policies and procedures, as well as, support operational excellence initiatives.


Required Qualifications :


  • BS Science or Engineering

  • Minimum 5 years of experience executing, developing, and administrating GMP quality programs in clinical and commercial manufacturing for biotech or pharmaceutical.

  • Minimum 3 years of recent supervisory experience, organizing and leading teams.

  • Knowledge of FDA and EMEA regulation.

  • Working knowledge of root cause analysis.

  • Knowledge of quality system applications, including the use of electronic system for training, deviation, CAPA management etc.

  • Experience in authoring, reviewing, and approving GMP documents.

  • Experience in participating in health authority inspection and client audits.

  • Up to a 20% bonus on top of salary is possible.



Contact: Allan Berman


To search all of our 100+ jobs, please visit www.EngineeringResource.com
Please send all inquiries to AB@EngineeringResource.com


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About the Company

Engineering Resource Group logo

Engineering Resource Group


We are different from all the other engineering staffing firms!

All of our account executives and recruiters have at least a four year engineering degree and at least five years engineering industry experience. This ensures the highest level of competence and professionalism in the staffing industry, delivering the best possible service to both our clients and our candidates.

Our account executives / recruiters average more than eight years of experience with us. This means that, if need be, the recruiter you work with today will be the same one you work with next year and five years from now.

Call us and speak to our management or to one of our recruiters and find out what we mean when we say:
“Engineering Staffing by Engineering Professionals, Since 1991”

Engineering Resource Group provides the industry with engineers and engineering support staffing for both contract / temporary and direct / permanent jobs.

Engineering Resource Group Inc.
We are different from all the other engineering staffing firms!

All of our account executives and recruiters have at least a four year engineering degree and at least five years engineering industry experience. This ensures the highest level of competence and professionalism in the staffing industry, delivering the best possible service to both our clients and our candidates.

Our account executives / recruiters average more than eight years of experience with us. This means that, if need be, the recruiter you work with today will be the same one you work with next year and five years from now.

Call us and speak to our management or to one of our recruiters and find out what we mean when we say:
“Engineering Staffing by Engineering Professionals, Since 1991”

Engineering Resource Group provides the industry with engineers and engineering support staffing for both contract / temporary and direct / permanent jobs.

COMPANY DETAILS
COMPANY SIZE
100 to 499 employees
INDUSTRY
Engineering Services
FOUNDED
1991
WEBSITE
http://www.EngineeringResource.com