Job Description
We are seeking a highly motivated and detail-oriented Quality Specialist to support batch record review and product release activities at a Contract Manufacturing Organization (CMO) for advanced cell and gene therapy products. This individual will serve as the sponsor’s Quality representative, ensuring compliance with cGMP standards and regulatory expectations while facilitating timely batch disposition.
Key Responsibilities:
-Act as the sponsor’s primary Quality point of contact at the CMO for manufacturing and quality-related decisions.
-Perform detailed review of batch records, manufacturing documentation, and associated quality records to support timely batch release.
-Collaborate with CMO teams to resolve manufacturing issues, deviations, and discrepancies in real time.
-Review and approve investigations, change controls, and complaints related to manufacturing activities.
-Drive compliance initiatives to reduce non-conformances and improve documentation practices.
-Ensure adherence to cGMP regulations, internal quality standards, and applicable safety policies.
-Participate in audits, inspections, and readiness activities as needed.
-Support continuous improvement initiatives and quality system enhancements.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
-Bachelor degree in Scientific field
-Minimum 5+ years of experience working with GMP pharmaceutical manufacturing
-Expertise handing review and approval of batch record review, RFFP activities, CAPAs, Change Controls, deviations, quality product complaints, and risk assessments
-Previous experience with CMO/CDMO relationships
-Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
-Excellent computer proficiency e.g MS Office, TrackWise, Minitab
-Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
-Ability to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
Nice to Have Skills & Experience
-Experience with CAR-T
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.