Quality Specialist, PathoQuest, Inc.

Job Description - Quality Specialist, PathoQuest, Inc.

PathoQuest SAS, a spin-out of Institut Pasteur, offers a wide range of innovative next generation sequencing (NGS)-based solutions to the biotech and biopharma industries with a goal to assure the safety and rapid commercialization of biologics. With a focus on rapidly advancing cell and gene therapies and viral vaccine safety, and to further expand our capabilities and strengthen our strategic partnership with Charles Rivers Laboratories (a leading provider of preclinical/clinical laboratory services for the pharmaceutical, medical device and biotechnology industries), PathoQuest SAS, based in Paris France, has recently established a state-of-the-art US subsidiary, PathoQuest Inc., in the Philadelphia metropolitan area. We are currently looking to hire an experienced Quality Specialist with NGS experience to support our growing US-based activities This position will report directly to PathoQuest’s global Quality and Regulatory Director.

Responsibilities

*Identify and set appropriate quality standards and communicate these standards and requirements internally, as appropriate.

*Support the adaptation of PathoQuest’s quality system across PathoQuest’s global organization.

* Review quality documentation such as SOPs, laboratory records (raw data, batch records, protocols, production records, study documentation, certificates of analysis, technical specifications, etc), deviation records, vendor qualification forms, and other corporate documents to ensure full compliance with current regulations.

*Lead efforts associated with the installation, operational performance and maintenance qualification of laboratory equipment.

*Lead efforts with monitoring and management of the company’s laboratory environment control system

*Support PathoQuest’s deviation, investigation, and CAPA process and implement out of specification (OOS) and out of thrend (OOT) investigations, as warranted.

*Manage and track Key Performance indicator (KPI) quality metrics.

*Define validation protocols for computerized laboratory and environment monitoring systems per FDA’s 21 CFR Part 11 and the European Union’s Annex 11

*Lead the development and ongoing implementation of quality control training programs.

* Ensure staff are sufficiently trained in current regulatory requirements and supporting activities within a regulated environment.

*Support the development, validation, and implementation of the company’s laboratory cleaning protocol.

Support the review and in-process audit of study and analysis files and data.

*Optimize and maintain the traceability and security of lab and testing data generated.

*Laise closely with management and support teams (program management) to ensure customer satisfaction with all offerings.

* Maintain appropriate professional certifications, training, and technical knowledge pertinent to job function and responsibilities.

*Conduct audits (study/client/vendor) to ensure testing is performed in accordance with all standard operating procedures (SOPs), current regulations (cGMP/GLP) and local practices.

* Conduct laboratory/facility inspections as per regulations and corporate policy

*Lead by example to ensure scientific and operational integrity.

* Promote a culture of continuous improvement; act as champion on initiatives and/or projects to drive improvement in quality and/or client service.

Qualifications and Skills

Experience and Education

 Required:

* BA/BS with six (6) or more years, or MA/MS with three (3) or more years of experience in a scientific or technical discipline. This must include a minimum of six (6) months of experience specifically with a Quality Assurance or Quality Excellence group within a Gxp environment.

*Strong working experience and knowledge of FDA (21CFR parts 11, 58, 210, 211, etc) and International regulations (EMA, MHRA, ICHQ10 and ICHQ9, OECD requirements)

*Experience associated with the analysis of data, deviation review, and change control.

*Experience participating in regulatory, vendor or internal audits.

 Experience leading, supervising, coaching, and training staff in quality requirements.

Required Skills and Qualifications

*Excellent oral and written communication, critical-thinking, time-management, and resolution-finding skills

*Familiarity with next-generation sequencing (NGS) technology and its application

* Strong leadership skills and an ability to work in a dynamic, entrepreneurial environment as part of a diverse team.

*Ability to present technical information to a broad audience.

*Candidates must be currently eligible to work in the United states.

*Candidates must reside in the Philadelphia metro area. No relocation package is available.

 Partial List of Benefits:

*Company subsidized healthcare insurance with flexible spending account (FSA)

* 401(k) retirement savings account with company match

* Paid Time Off (PTO) and work-related incentive programs