Quality Assurance Specialist - Manufacturing (Rockville, MD)

ANTAGENE

5d•$63,000 - $79,000•Onsite

About The Position

The Quality Assurance Specialist supports daily Quality Assurance and compliance operations across manufacturing, distribution, and biobank facilities. Under general supervision from the Quality Manager, the role ensures that products, processes, raw materials, and finished goods conform to corporate Mars QMS requirements, ISO 9001, USDA, CFIA, and biobanking standards. Core quality gatekeeping work includes Batch Production Record review, floor audits, out-of-specification investigations, incoming and finished goods inspection, and maintenance of the Electronic Quality Management System. The role works with cross-functional teams to investigate deviations and nonconformances, implement corrective and preventive actions, maintain controlled documents and quality archives, monitor environmental conditions and quality trends, and support verification and validation activities. It also collaborates on product development, transfer, and scale-up initiatives to promote continuous improvement, yield optimization, and risk reduction. Work is split between an office environment and operational plant, laboratory, cleanroom, compounding, and cold-storage or cryogenic biobank settings. Occasional travel is required. The position is based in Rockville, Maryland, and the stated target pay range is $63,000 to $79,000 annually.

Requirements

Bachelor's degree in a life sciences discipline, Medical Technology, Biomedical Engineering, or an applicable technical field.
At least 3–5+ years of hands-on Quality Assurance or Quality Control experience, preferably in a regulated diagnostic, manufacturing, or life science laboratory environment.
Familiarity with cGMP, GLP, GDP, QSR, ISO 9001, CFIA, and USDA standards.
Proficiency in quality tools such as CAPA, FMEA, Root Cause Analysis, and 8D.
Familiarity with Electronic Quality Management Systems, such as Ideagen, and enterprise inventory or ERP platforms.
Experience managing nonconforming materials, investigations, and dispositions.
Strong root-cause investigation capabilities.
Detail-oriented, with strong analytical, document-review, and problem-solving skills.
Excellent written and verbal communication skills and the ability to interact constructively with operations, QC, R&D, and management.
Proficiency in Microsoft Office Suite and modern QMS, ERP, or inventory database software.
Ability to meet the physical demands of the role, including occasional lifting or moving of up to 25 pounds.

Nice To Haves

Experience supporting biological diagnostic manufacturing in a USDA-licensed, CFIA-regulated, or ISO 9001-certified facility.
Knowledge of aseptic manufacturing and cleanroom compliance requirements.
Experience supporting regulatory inspections, including USDA CVB, FDA CVM, or CFIA inspections.
Working understanding of diagnostic laboratory assays such as PCR, ELISA, and wet chemistry, and of analytical instrumentation.
Ability to use statistical software tools to analyze quality trends and detect product variances.

Responsibilities

Review and verify daily Batch Production Records, product release records, standard operating logs, and testing documentation against manufactured products for data integrity, completeness, and GDP compliance.
Approve final product release after verifying product labeling, packaging, and storage conditions.
Initiate, investigate, and document out-of-specification results, process deviations, customer complaints, and nonconformances.
Assist cross-functional root-cause analyses and ensure effective corrective and preventive actions are implemented using established problem-solving tools.
Track CAPA milestones in the EQMS to support timely implementation, closure, and effectiveness verification.
Maintain quality system processes in compliance with applicable regulatory standards, including USDA APHIS, CFIA, FDA CVM, and ISO requirements.
Qualify, monitor, and evaluate suppliers to ensure materials and services meet quality, regulatory, and business requirements.
Conduct internal QMS walkthroughs and technical floor audits across manufacturing departments, compounding areas, testing labs, and biobank or biorepository storage rooms.
Monitor ambient and cold-chain environmental parameters and verify specimen storage units, freezers, and cleanrooms meet established specifications.
Identify operational non-compliance or procedural drift and partner with managers and supervisors to drive corrections.
Review and update controlled documents in the EQMS, including standard operating procedures, raw material specifications, Batch Records, Test Methods, and forms.
Maintain physical and digital QA archives, including batch folders, calibration logs, and qualification records.
When needed, conduct analytical and visual testing of raw materials, in-process intermediates, and finished goods, and document findings in batch quality records.
Support verification and validation protocols for equipment, analytical methods, raw material vendors, utilities, and manufacturing processes.
Monitor statistical process control charts for diagnostic testing and compounding processes to detect quality drift.
Handle documentation for hazardous chemicals and low-level diagnostic materials according to company safety protocols and applicable USDA, CFIA, and NRC guidelines.
Represent Quality on design and development project teams.
Collaborate with Manufacturing, QC, R&D, Operations, and Regulatory teams on product transfer and scale-up, and analyze quality trends to support continuous improvement, yield optimization, and risk reduction.
Perform other related duties as assigned by leadership.
Ask questions, seek guidance, and report concerns or violations of company policy or ethical standards.