QA Sr. Operations Specialist

Company: CARsgen Therapeutics
Location: Raleigh
Posted on: March 19, 2023

Job Description:

QA Sr. Operations Specialist

TOGETHER, WE MAKE CANCER CURABLE
Led by an experienced management team of academic professionals and industry veterans, we have built an integrated cell therapy platform with in-house capabilities that span from target discovery, lead antibody development, clinical studies to commercial-scale manufacturing. Our vision is to become a leading biopharmaceutical company developing globally revolutionary cell therapies to make cancer curable. If you are looking for an opportunity with an innovative and solidly growing company, join us.

Responsibilities

The Senior Quality Assurance (QA) Operations Specialist for Gene Therapy Manufacturing will be a key team member for start-up and operation of CARsgen's facility.
Sr.QA Operations Specialist will be responsible for product batch record reviews, batch release and batch disposition
Oversees production room clearances and provides the QA support on the floor
Oversee and assist the deviation investigations and ensuring the on-time closure of the deviations.
Review manufacturing master batch records and SOPs to ensure them compliance with the regulatory requirements.
Support quality audit activities including regulatory inspections and internal audits.
Create, revise and implement quality assurance standard operation procedures and work instructions for the site when necessary.
Support the Quality System with emphasis on the following processes: Change Control, Deviation, Out of Specification, Out of Trend, and CAPA.
Conduct data analysis to support tracking of Key Quality Performance Indicators and generate the quality metrics monthly reports.
Implement strategy for tracking and reporting on Quality Metrics and Site Compliance
Ensure Manufacturing operation is inspection-ready and directly support inspection activities
Support the documentation lifecycle management, including document creation, approval, retention, obsolete, and archiving for the site
Lead/support internal audits and assist regulatory inspections (e.g., prep room participant, subscriber)
Support site training activities including developing training SOPs, training materials and training matrix and providing training for new employees.
Maintain updated knowledge and relevant assessments of the GxP landscape, regulations, and guidelines pertaining to Quality Systems.
Drives continuous improvement efforts regarding Operations as it relates to Quality Management processes by identifying improvement opportunities and presenting solutions to the improvement opportunities.

Qualifications

Degree in Biology, Microbiology, Biochemistry, or other life sciences from an accredited university or college
8+ years of experience in QA or GMP environment or equivalent.
Working experience in Biotechnology is highly desired but working experience in pharmaceuticals or related field such as cell therapy is a must.
Strong working knowledge of GMP Regulations and ICH Guidelines governing current Good Manufacturing Practices for Pharmaceuticals and Biotechnologies.
Must be comfortable in a fast-paced environment with minimal direction and changing priorities
Strong interpersonal skills and ability to work collaboratively across functions
Inter- and intra-departmental project experience is highly desired.
Growth-oriented with a continuous improvement mindset, and passionate about working with others in a complex manufacturing environment.
Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.
Goal oriented with the ability to troubleshoot and resolve problems.

CARSGEN THERAPEUTICS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identity, or any other protected class.

To all agencies: Please, no phone calls or emails to any employee of CARsgen about this requisition. All resumes submitted by search firms/employment agencies to any employee at CARSGEN THERAPEUTICS via email, the internet, or in any form and/or method will be deemed the sole property of CARSGEN THERAPEUTICS unless such search firms/employment agencies were engaged by CARSGEN THERAPEUTICS for this requisition and a valid agreement with CARSGEN THERAPEUTICS is in place. In the event a candidate who was submitted outside of the CARSGEN THERAPEUTICS agency engagement process is hired, no fee or payment of any kind will be paid.

Keywords: CARsgen Therapeutics, Raleigh , QA Sr. Operations Specialist, Other , Raleigh, North Carolina