Quality Assurance Specialist - Manufacturing (Rockville, MD)

Antech Diagnostics•Rockville, MD

5d•$63,000 - $79,000

About The Position

The Quality Assurance Specialist supports daily Quality Assurance and compliance operations across manufacturing, distribution, and biobank facilities. Working under general supervision from the Quality Manager, the position ensures that products, processes, raw materials, and finished goods conform to corporate Mars QMS requirements, ISO 9001, USDA, CFIA, and biobanking standards. The role performs quality gatekeeping, including Batch Production Record review, floor audits, OOS investigations, incoming and finished-goods inspection, and maintenance of the Electronic Quality Management System (EQMS). The Specialist reviews production and testing records, approves final product release, manages investigations and CAPAs, maintains controlled documentation and quality archives, monitors environmental and process quality, and supports audits and verification and validation activities. The role collaborates with manufacturing, QC, R&D, operations, and regulatory teams on product transfer, scale-up, continuous improvement, yield optimization, and risk reduction. Occasional travel is required.

Requirements

Bachelor’s degree in life sciences, Medical Technology, Biomedical Engineering, or an applicable technical field.
A minimum of 3–5+ years of hands-on Quality Assurance or Quality Control experience; experience in a regulated diagnostic, manufacturing, or life science laboratory environment is preferred.
Familiarity with cGMP, GLP, GDP, QSR, ISO 9001, CFIA, and USDA standards.
Proficiency with quality tools such as CAPA, FMEA, Root Cause Analysis, and 8D.
Familiarity with Electronic Quality Management Systems and enterprise inventory or ERP platforms.
Experience managing nonconforming materials, investigations, and dispositions.
Strong root-cause investigation capabilities.
Strong attention to detail, analytical, document-review, and problem-solving skills.
Excellent written and verbal communication skills and ability to work constructively with operations, QC, R&D, and management.
Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, and Teams, and modern QMS, ERP, or inventory database software.
Ability to work in laboratory, plant, cleanroom, compounding, testing, and cold-storage environments and use required personal protective equipment.
Ability to occasionally lift and/or move 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 analytical instrumentation.
Ability to use statistical software tools to analyze quality trends and detect product variances.

Responsibilities

Review and verify 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 corrective and preventive actions are implemented; track CAPA milestones and verify timely closure and effectiveness in the EQMS.
Maintain quality system processes in compliance with applicable regulatory standards, including USDA APHIS, CFIA, FDA CVM, and ISO.
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 storage units, freezers, and cleanrooms meet established specifications.
Identify operational non-compliance or procedural drift and work with departmental managers and supervisors to drive corrections.
Review and update controlled documents in the EQMS, including SOPs, raw material specifications, Batch Records, Test Methods, and other controlled forms.
Maintain physical and digital QA archives, including batch folders, calibration logs, and qualification records, so they are retrievable for audits.
When needed, perform 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 by organizing test data and reviewing validation documentation.
Monitor statistical process control charts, including Levey-Jennings charts, to detect quality drifts in diagnostic testing and compounding processes.
Handle documentation for hazardous chemicals and low-level diagnostic materials according to company safety protocols and 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, analyzing 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.