About this role
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
Responsibilities
- Provide on‑floor QA support during GMP manufacturing to ensure compliance with procedures and cGMP standards.
- Participate in the QA walkthrough program to identify potential gaps/issues in the GMP facility.
- Escalate quality issues promptly and support real‑time troubleshooting.
- Support batch disposition through compilation of required documentation.
- Review batch records, logbooks, and GMP documentation for completeness and.
- Review incoming material disposition packets and verify documentation completeness.
- Perform QA review of SOPs, forms, protocols, and other controlled documents.
- Contribute to quality improvement, lean initiatives, and process efficiency projects.
- Assist across Quality functions including document control, training, audits, and systems.
- Communicate effectively with cross‑functional teams and uphold company quality standards and policies.
Qualifications
- Bachelor’s degree in science or engineering, or equivalent experience.
- 0-3+ years of relevant experience in a GMP‑regulated biopharmaceutical environment.
- Working knowledge of GMP regulations (US, EU, ROW), GDP, 21 CFR, USP, and applicable standards.
- Strong attention to detail and effective written and verbal communication skills.
- Ability to work independently and cross functionally on common goals.
Physical Requirements
- Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
- Frequently lift and or move objects up to 30 pounds.
- Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.