Quality Engineer II (Rockville, MD)

Antech

1d•Onsite

About The Position

We are seeking a detail-oriented and proactive Quality Engineer with experience in veterinary biotechnology to join our growing team. In this role, you will ensure all biotech products, ranging from vaccines to diagnostic tools, meet internal quality standards and comply with veterinary industry regulations. You will work cross-functionally to support product development, manufacturing, and compliance throughout the product lifecycle.

Requirements

Bachelor's degree in biotechnology, Biomedical Engineering, Biology, or related field.
A minimum of 4-7+ years of quality assurance experience, preferably in a regulated industry or equivalent combination of education and experience.
Familiarity with GMP, GLP, QSR, and ISO 9001/13485 standards.
Experience managing nonconforming materials, investigations, and dispositions.
Proficiency in quality tools such as CAPA, FMEA, Root Cause Analysis, and 8D.
Solid documentation, analytical, and communication skills.

Nice To Haves

Experience supporting biologics manufacturing in a USDA-licensed facility.
Knowledge of aseptic manufacturing and cleanroom compliance requirements.
Certified Quality Engineer (CQE) or Six Sigma certification.
Experience supporting regulatory inspections (USDA CVB, FDA CVM).
Knowledge of veterinary biologic regulations (e.g., USDA Center for Veterinary Biologics).

Responsibilities

Provide quality engineering support to manufacturing operations, including batch record review, deviation management, and in-process control monitoring.
Assist in resolving quality issues on the production floor by collaborating with manufacturing, quality control, and engineering teams.
Implement, and maintain quality systems in compliance with standard requirements and regulations (e.g., USDA APHIS, FDA CVM, ISO).
Support validation and qualification of manufacturing equipment, utilities, and processes (IQ/OQ/PQ).
Manage Nonconforming Material Reports (NCMRs), including investigation, segregation, documentation, and disposition of nonconforming products, and leading the Material Review Board.
Lead and participate in root cause investigations and implement corrective and preventive actions (CAPA) related to manufacturing deviations and product issues.
Collaborate with Operations, R&D and regulatory teams during the development and scale-up of new products.
Analyze trends in manufacturing quality data to identify opportunities for continuous improvement and risk reduction.
Support lot release testing, stability studies, and regulatory compliance activities.
Conduct and support internal and external audits, including USDA CVB and FDA CVM inspections.
Maintain and improve quality system documentation, such as batch records, part specifications, manufacturing travelers, etc.
Ensure supplier-provided materials meet quality standards and support incoming inspections.
Provide training on GMP, GLP, and manufacturing-related quality practices.