Sr. Specialist, Quality Systems

GenScript Biotech Corp.; Northern (KY); Hybrid; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with company match

Parental leave

Paid time off

FSA/HSA

Job summary

GenScript Biotech Corporation, via its ProBio Inc. unit in the United States, seeks a QA professional to administer and improve the Quality Management System for Cell and Gene Therapy products.

You will handle deviations, CAPA, change controls, investigations, risk management, and document control to ensure global GxP compliance. You will collaborate with internal and external teams to sustain inspection readiness, drive quality metrics, and support regulatory inspections while maintaining

Qualifications

• Bachelor’s degree in a scientific discipline with 3+ years of QA/GxP experience in pharma/biotech.
• Experience with GxP document management systems and QMS platforms (e.g., Veeva, TrackWise).
• Knowledge of GxP Document Control, Change Control, CAPA, Deviations, and Lab investigations.
• Solid understanding of GMP regulations and regulatory requirements.
• Strong communication and documentation skills; able to work virtually and collaboratively.

Responsibilities

• Maintain and improve QMS for clinical and commercial C&GT products to ensure GxP compliance.
• Review and approve Change Controls, CAPAs, Deviations, and Investigations per QA procedures.
• Support root cause analysis and effective CAPA implementation with timely verification.
• Monitor quality metrics and overdue actions; report on KPIs.
• Participate in audits, inspections, and customer inquiry responses.
• Coordinate readiness for regulatory inspections and internal audits.

Skills

GxP QA

QMS

CAPA

Change Control

Deviation Investigation

Root Cause Analysis

Regulatory Compliance

Documentation Control

Communication

Education

Bachelor’s degree in a scientific discipline

Tools

Veeva QualityDocs

Veeva QMS

TrackWise

Job description

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

About ProBio

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017.

About the job

Contributes to the administration, maintenance, and continuous improvement of ProBio’s Quality Management System (QMS) to ensure compliance with applicable GMP regulations, industry standards, and company procedures for both clinical andcommercial Cell and Gene Therapy products. This role supports quality system processes including deviations, lab investigations, Corrective and Preventative Actions (CAPA), change controls, complaints, risk management, training, document control, management review, and regulatory inspection readiness.

The position collaborates cross-functionally with internal teams, customers, and external resources (when required) to ensure compliance and drive a culture of quality and operational excellence.

Responsibilities

Quality Management System (QMS)

• Maintain and continuously improve ProBio Inc. and external Quality Management Systems ensuring GxP compliance with worldwide manufacturing regulations, guidelines, and current regulatory requirements for both clinical and commercial Cell and Gene Therapy products manufactured and/or tested at the Hopewell, NJ facility.
• Manage and perform Quality Assurance (QA) review and approval of documentation related to Change Control, Corrective and Preventative Action (CAPA), Deviations, Laboratory Investigations, incidents, complaints, exceptions, and Out of Specification (OOS) reports as generated by ProBio Hopewell, NJ facility in accordance with current QA procedures.
• Facilitate and support ProBio internal team members with Root Cause Analysis and Investigations using established methodologies. Drives completion of Investigations and ensures timely implementation and effectiveness verification of CAPAs as needed.
• Monitor quality system performance and overdue actions.
• Support development, implementation, and monitoring of quality metrics and Key Performance Indicators (KPIs).
• Analyze quality trends and generate quality management review reports. Recommend and implement process improvements to enhance effectiveness and compliance.

Inspection and Audit Support

• Participate in customer audits, regulatory inspections, and internal audits.
• Coordinate responses to audit observations and inspection findings.
• Maintain inspection readiness at all times.

Performs other tasks and assignments as needed and specified by management.

Qualifications

• Bachelor’s degree in a scientific discipline with 3+ years of experience in QA or related role(s) in a pharmaceutical, biotechnology or related environment.
• Demonstrated experience with GxP document management systems and/or other QMS (e.g. Veeva QualityDocs, Veeva QMS, TrackWise QMS etc.).
• Demonstrated knowledge and understanding of business practices and procedures associated with GxP Document Control, Change Control, CAPA, Deviation and/or Lab investigations.
• In-depth knowledge of quality risk management, Root Cause Analysis, and appropriate investigation tools.
• Demonstrated understanding biologics manufacturing and laboratory activities.
• Detailed knowledge and understanding of GMP regulations and compliance regulatory
  requirements.
• Demonstrated ability to communicate proactively with a positive customer service attitude.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• Ability to work virtually, independently, and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Pay range is estimated between $70k - $90k based on skill set and experience.

#AH

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.