We understand that the world we want tomorrow starts with how we do business today, and that's why we're inspired to make A Better World for Pets. Antech is comprised of a diverse team of individuals who are committed to each other's growth and development. Our culture is centered on our guiding philosophy, The Five Principles: Quality, Responsibility, Mutuality, Efficiency and Freedom. Today Antech is driving the future of pet health as part of Mars Science & Diagnostics, a family-owned company focused on veterinary care.
Current Associates will need to apply through the internal career site. Please log into Workday and click on Menu or View All Apps, select the Jobs Hub app, then click the magnifying glass to Browse Jobs.
The Target Pay Range for this position is $63,000 to $79,000 annually. At Antech, pay decisions are determined using factors such as relevant job-related skills, experience, education, training, and budget.
Job Purpose/Overview
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, this position ensures that products, processes, raw materials, and finished goods consistently conform to corporate Mars QMS requirements, ISO 9001, USDA, CFIA, and biobanking standards. This role executes crucial quality gatekeeping duties, including Batch Production Record (BPR) review, floor audits, out-of-specifications (OOS) investigations, inspection of incoming/finished goods, and maintenance of the Electronic Quality Management System (EQMS).
Essential Duties and Responsibilities
Perform thorough daily review and verification of BPRs/product release records, standard operating logs, and testing documentation against physical manufactured products to ensure data integrity, completeness, and adherence to GDP.
Approve final product release, ensuring inspection/verification of product labeling, packaging, and storage conditions is completed prior to approval.
Initiate, investigate, and document OOS results, process deviations, customer complaints, and nonconformances.
Assist in root-cause analyses (RCA) investigations alongside cross-functional teams (QC, R&D, Production, Operations, Warehouse) and ensure effective corrective and preventative actions (CAPA) using established problem-solving tools (e.g., 5 Whys, Fishbone diagrams) are implemented.
Track CAPA milestones within the EQMS to ensure timely implementation, closure, and verification of effectiveness.
Maintain quality system processes in compliance with regulatory standards (e.g., USDA APHIS, CFIA, FDA CVM, ISO).
Implement supplier quality management activities by qualifying, monitoring, and evaluating supplier performance to ensure materials and services consistently meet quality, regulatory, and business requirements.
Conduct routine internal QMS walkthroughs and technical floor audits across manufacturing departments, compounding areas, testing labs, and biobank/biorepository storage rooms to maintain audit readiness.
Monitor ambient and cold-chain environmental parameters, verifying that specimen storage units, freezers, and cleanrooms adhere to established environmental specifications.
Identify operational non-compliance or procedural drift and partner with departmental managers/supervisors to drive immediate corrections.
Review and update as needed controlled documents through the EQMS (Ideagen), ensuring standard operating procedures, raw material specifications, Batch Records, Test Methods, and all other controlled forms for correctness.
Maintain physical and digital QA archives, ensuring batch folders, calibration logs, and qualification records remain readily retrievable for internal and third-party audits.
If needed, execute analytical and visual testing across raw materials, in-process intermediates, and finished goods (e.g., PCR, ELISA, wet chemistry, radioactive/fluorescent assays), documenting findings in batch quality records.
Support the execution of Verification and Validation (V&V) 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 (e.g., Levey-Jennings charts) for diagnostic testing and compounding processes to detect quality drifts.
Handle documentation associated with hazardous chemicals and low-level diagnostic materials in accordance with established company safety protocols and USDA, CFIA, & NRC safety guidelines.
Represent Quality on design and development project teams.
Collaborate cross-functionally with Manufacturing, QC, R&D, Operations, and Regulatory teams on new product transfer and scale-up, analyzing quality trends to drive continuous improvement, yield optimization, and risk reduction.
Perform other related duties as assigned by leadership.
We share a collaborative obligation to ensure that we conduct ourselves in the utmost ethical manner and that we hold each other accountable to the values and standards of the organization. Every employee is responsible for asking questions, seeking guidance, and reporting concerns and/or violations of company policy or ethical standards. Antech Diagnostics has several processes to communicate with leadership and expects that employees will have a commitment to integrity and uncompromising values.
Education and Experience
Bachelor's degree in Life sciences discipline (Biology, Chemistry, Biochemistry), Medical Technology, Biomedical Engineering, or an applicable technical field.
A minimum of 3-5+ years of hands-on Quality Assurance or Quality Control experience, preferably in a regulated diagnostic, manufacturing or life science laboratory environment (e.g., IVD, medical device, biotech, or ISO accredited testing facility).
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 (e.g., Ideagen) and enterprise inventory/ERP platforms.
Knowledge, Skills and Abilities
Experience managing nonconforming materials, investigations, and dispositions.
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 (USDA CVB, FDA CVM, CFIA).
Strong root cause investigation capabilities.
Working understanding of diagnostic laboratory assays (e.g., PCR, ELISA, wet chemistry) and analytical instrumentation.
Able to utilize statistical software tools to analyze quality trends and detect product variances.
· Detail-oriented with strong analytical, document-review, and problem-solving skills.
· Excellent written and verbal communication skills; ability to interact constructively with operations, QC, R&D, and management.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Teams) and modern QMS/ERP/inventory database software.
Travel
Will there be notable travel in this position? Yes (Occasional)
Working Conditions
Split between a typical office environment (cubicles, computers, moderate noise levels) and operational plant, laboratory, and cold storage / cryogenic biobank settings.
Periodic work within controlled cleanrooms, compounding suites, testing areas, and cold storage requiring standard PPE (bouffant caps, safety glasses, lab coats, gloves, thermal protective gloves/face shields for cryogenic units, shoe covers).
Laboratory environment with exposure to biohazards and hazardous chemicals (per National Hazard Communication Standards) and small quantities of radioactive material.
The associate is regularly required to apply manual dexterity, including hand/wrist flexibility, for computer keyboarding. The associate frequently is required to sit for extended periods of time, stand, walk, and reach with hands and arms. The associate is frequently required to hear and speak using the telephone, make presentations, and communicate with people in an office environment. The associate is occasionally required to sit and stoop, bend, kneel, or crouch. The associate must occasionally lift and/or move up to 25 pounds.
The associate will primarily work in a typical office environment including use of cubicles, computers and overhead lighting. Temperature extremes will be minimal to nonexistent. The noise level in the work environment is usually moderate. The associate will be required to use a computer, spreadsheets, database management, email, and the Internet. The associate is frequently required to use a calculator; fax, copy machine, and phone system. The associate must occasionally use media equipment such as an overhead projector, PowerPoint, and Microsoft Teams.
About Antech
Antech is a leader in veterinary diagnostics, driven by our passion for innovation that delivers better animal health outcomes. Our products and services span 90+ reference laboratories around the globe; in-house diagnostic laboratory instruments and consumables, including rapid assay diagnostic products and digital cytology services; local and cloud-based data services; practice information management software and related software and support; veterinary imaging and technology; veterinary professional education and training; and board-certified specialist support services.
Benefits
Antech offers an industry competitive benefits package and continues to invest in and evolve benefits programs that meet the health, wellness and financial needs of our associates.
Benefits eligiblity is based on employment status.
Paid Time Off & Holidays
Medical, Dental, Vision (Multiple Plans Available)
Basic Life (Company Paid) & Supplemental Life
Short and Long Term Disability (Company Paid)
Flexible Spending Accounts/Health Savings Accounts
Paid Parental Leave
401(k) with company match
Tuition/Continuing Education Reimbursement
Life Assistance Program
Pet Care Discounts
Commitment to Equal Employer Opportunities
We are proud to be an Equal Opportunity Employer. For a complete EEO statement, please see our Career page at Antech Careers (http://careers.antechdiagnostics.com/us/en/affirmative-action) .
Note to Search Firms/Agencies
Antech Diagnostics, Inc. and its subsidiaries and affiliates (Antech) do not compensate search firms for unsolicited assistance unless they have a written search agreement with Antech and the requisition is position-specific. Any resumes, curriculum vitae, and other unsolicited assistance from search firms that do not have a written search agreement or position-specific requisition submitted to any Associate of Antech will be deemed the sole property of Antech and no fee will be paid in the event the candidate is hired by Antech.
