Randstad USA
Join a pioneering biotechnology company at the forefront of creating a new generation of transformative medicines. We are seeking a meticulous and experienced
Quality Control Data Review Specialist
to support our QC Bioassay laboratory. In this critical role, you will be the gatekeeper of data integrity, ensuring that our life‑saving products meet the highest standards of safety and quality. This is an opportunity to make a tangible impact within a high‑growth, collaborative, and science‑driven organization.
What You’ll Do
Ensure Product Integrity:
Meticulously review executed QC Bioassay test records (e.g.,
DNA Sequencing ,
PCR ,
Electrophoresis ) to support the timely release of products.
Drive Quality & Compliance:
Author and manage essential quality system records, including deviations, change controls, CAPAs, and laboratory investigations, to ensure adherence to cGMP standards.
Strengthen Laboratory Operations:
Author, revise, and maintain critical cGMP documents, such as standard operating procedures (SOPs), technical reports, and training materials.
Collaborate on Problem‑Solving:
Partner with the QC lab team to investigate assay failures, troubleshoot technical issues, and identify effective resolutions.
Support Team Development:
Assist in maintaining and updating all necessary training documentation to enhance team competency and readiness.
Essential Qualifications (Must‑Haves)
A Bachelor's degree in Biology, Chemistry, or a related scientific field.
3‑5 years of direct experience working in a
cGMP
Quality Control laboratory environment.
Hands‑on experience with
bioassay methods
such as
DNA Sequencing ,
Electrophoresis ,
PCR , Residual Protein Assays, or Cell Culture.
Preferred Qualifications (Bonus Points)
Previous experience specifically focused on reviewing laboratory data and audit trails for
GDP/GMP compliance .
Proven experience authoring and managing quality records like change controls, deviations, and laboratory investigations.
Why You’ll Love This Role
Be Part of the Future:
Contribute to a high‑growth, transformational company that is relentlessly curious and collaborative in its mission to change medicine.
Critical Impact:
Play a vital, hands‑on role in the quality control process for innovative therapies.
Stable Schedule:
Enjoy a consistent first‑shift, Monday‑to‑Friday work week.
Ready to Apply? If you are passionate about quality and ready to make a significant impact, we encourage you to apply now!
Send your resume to michael.wilson@randstadusa.com, with NORWOOD in the subject line.
Seniority level Mid‑Senior level
Employment type Contract
Job function Quality Assurance and Production
Industries Biotechnology Research and Pharmaceutical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
Disability insurance
#J-18808-Ljbffr
Quality Control Data Review Specialist
to support our QC Bioassay laboratory. In this critical role, you will be the gatekeeper of data integrity, ensuring that our life‑saving products meet the highest standards of safety and quality. This is an opportunity to make a tangible impact within a high‑growth, collaborative, and science‑driven organization.
What You’ll Do
Ensure Product Integrity:
Meticulously review executed QC Bioassay test records (e.g.,
DNA Sequencing ,
PCR ,
Electrophoresis ) to support the timely release of products.
Drive Quality & Compliance:
Author and manage essential quality system records, including deviations, change controls, CAPAs, and laboratory investigations, to ensure adherence to cGMP standards.
Strengthen Laboratory Operations:
Author, revise, and maintain critical cGMP documents, such as standard operating procedures (SOPs), technical reports, and training materials.
Collaborate on Problem‑Solving:
Partner with the QC lab team to investigate assay failures, troubleshoot technical issues, and identify effective resolutions.
Support Team Development:
Assist in maintaining and updating all necessary training documentation to enhance team competency and readiness.
Essential Qualifications (Must‑Haves)
A Bachelor's degree in Biology, Chemistry, or a related scientific field.
3‑5 years of direct experience working in a
cGMP
Quality Control laboratory environment.
Hands‑on experience with
bioassay methods
such as
DNA Sequencing ,
Electrophoresis ,
PCR , Residual Protein Assays, or Cell Culture.
Preferred Qualifications (Bonus Points)
Previous experience specifically focused on reviewing laboratory data and audit trails for
GDP/GMP compliance .
Proven experience authoring and managing quality records like change controls, deviations, and laboratory investigations.
Why You’ll Love This Role
Be Part of the Future:
Contribute to a high‑growth, transformational company that is relentlessly curious and collaborative in its mission to change medicine.
Critical Impact:
Play a vital, hands‑on role in the quality control process for innovative therapies.
Stable Schedule:
Enjoy a consistent first‑shift, Monday‑to‑Friday work week.
Ready to Apply? If you are passionate about quality and ready to make a significant impact, we encourage you to apply now!
Send your resume to michael.wilson@randstadusa.com, with NORWOOD in the subject line.
Seniority level Mid‑Senior level
Employment type Contract
Job function Quality Assurance and Production
Industries Biotechnology Research and Pharmaceutical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
Disability insurance
#J-18808-Ljbffr