Allendale, New jersey
Quality Auditor Job Opening in Allendale, New jersey - Quality Auditor
We are seeking a highly motivated Quality Auditor who is interested in joining our fast-paced, dynamic environment.
The Quality Auditor will be responsible for performing internal audits for all PCT sites based on regulations, metrics from client audits and site deviations; enhancing the audit program for PCT by being a key active member of the Audit QTF (Quality Task Force); maintaining a list of audits; tracking audit deliverables for Clients and Internal audits to closure; performing cross-training with other QA staff to build skills within the PCT QA group for auditing as well as assisting Quality management with department needs. This position is based in Allendale, NJ.
Responsibilities:
Enhance the internal auditing program for PCT by being an active QTF team member
Perform internal self-assessment audits, including Corporate, Internal, Data Integrity review and Walk Through audits, for all PCT facilities,
Provide guidance and ideas on how to address internal audit findings and improvements in PCT systems.
Prepare internal audit schedule and conduct audits keeping to this approved schedule
Proactively track audit findings for Internal and Client audits to completion
Maintain metrics on Client audit findings and Internal audit findings ; Use these metrics to determine PCT vulnerable areas and perform audits of these areas
Maintain an audit list by year for Client audits for all PCT sites
Update the associated SOPs related to auditing, as
Support the supplier quality auditing function at all facilities, as needed
Perform cross-training with other QA staff to build skills within PCT QA group for auditing
Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs by setting the example
Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues.
Author and review relevant Quality SOPs, validations and other documents.
Education and Experience:
Minimum of 5 years of hands-on auditing experience in the biologics industry.
BS Degree in biological sciences or equivalent.
Understanding of Current Good Manufacturing Practices (cGMPs).
Understanding of the manufacture and testing of cellular and gene therapies is desirable.
Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc.
Sound knowledge of aseptic processing and supporting technologies.
Excellent organizational skills and attention to detail.
Ability to work independently and manage time successfully
Exceptional verbal and written communication skills required.
Strong team-oriented interpersonal skills are essential.
Ability to work as a self-directed sole contributor or as part of a team is essential.
25 ? 30% travel required.
Candidate Profile:
Must have exceptional written and oral communication skills
Exhibits professional mannerisms when dealing with Clients and PCT personnel
Ability to multi-task is
Relevant IT skills (Word, Excel, Outlook , PowerPoint)
Ability to think strategically and tactically (detail-oriented)
Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed
Analytical and problem solving skills
Flexible and able to adapt to company growth and evolving responsibilities.
About Us
PCT Cell Therapy Services, a Hitachi Group Company, is an industry leader in contract development and manufacture of cell therapy products. PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, full scale cGMP/GLP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support.
Our mission is to provide our clients with high quality, scalable, innovative, reliable, and cost efficient manufacturing platforms and services to advance commercialization of cellular therapies. We are in the business of developing innovative service products for cell therapy manufacture; selling these to senior leaders in charge of development programs in collaboration with their subject matter experts; and delivering these service products for the development and execution of cell-based therapy manufacturing directly to clinical and commercial development teams around the world.
Please connect with us on at
Follow us on Twitter @PCTcelltherapy
Job Type: Full-time
Job Location:
Allendale, NJ
Required education:
Bachelor's
Required experience:
Quality Auditing in a Biotechnology or Pharma Industry: 5 years
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