--- title: 'QC Analyst at BioAgilytix' canonical: 'https://feeny.ai/job/qc-analyst-bioagilytix-melbourne-qsw0pxqnxtwn' type: 'job' last_seen: '2026-10-30' --- # QC Analyst at BioAgilytix - **Company:** BioAgilytix - **Location:** Melbourne, Australia - **Work type:** hybrid - **Posted:** 2026-10-29 - **Last confirmed live:** 2026-10-30 - **Apply:** https://jobs.lever.co/bioagilytix/c7b832c2-398b-47b3-a410-dfb0a0be0714 ## Job description 360biolabs is Australia's most comprehensive quality-accredited specialty laboratory services organisation. 360biolabs is a BioAgilytix company and part of a leading global contract research organisation (CRO) supporting the development of innovative new medicines in a quality-controlled environment. At 360biolabs, we develop and conduct pharmacokinetics (PK) and pharmacodynamic (PD) assays across a wide variety of therapeutic areas to ensure the success of our clients' clinical trials and preclinical studies. Working at 360biolabs means working with the best people (and technology) in our field. With a genuine focus on development, you will have access to local and global opportunities. You will also have access to a diverse offering of wellbeing and connection initiatives which reflects that people are our priority. This role will be responsible for supporting the Scientific Operations team in the quality control of client reports and data transfers to ensure the quality and accuracy of the work performed and reported and to eliminate errors, and to perform this under the requirements of the company’s Quality Management System. Responsibility Areas - The key responsibility areas (KRAs) are major outputs for which the position is responsible and not a comprehensive statement of all position activities. Quality Control - Conduct systematic Quality Control reviews of client reports and data transfers - Deliver findings, observations and comments to scientific teams and conduct follow-up reviews - Lead the close out of QC reviews - Help ensure that high quality, accurate data are delivered to the client - Assist in identifying deviations, CAPA and lab investigations associated with laboratory data; and aid in addressing these where applicable Record Keeping and Document Work - Complete records as per required by company SOPs - May be required to review company documents (E.g. SOP revisions) as per applicable to the role Accreditation - Adhere to the company’s Quality Management System which includes all Standard Operating Procedures (SOPs), noting we operate under NATA accreditation (ISO/IEC 17025, OECD Principles of GLP, and GCLP Principles) and are required to comply with ICH Good Clinical Practice for all clinical studies - Complete training and maintain awareness of applicable standards, regulations and guidelines as per applicable to the role Safety - Ensure the safe and efficient conduct of activities - Ensure compliance to company OHS processes and statutory requirements Teamwork - Maintain effective communication with colleagues, service providers and other partners. - Work as a team both with QC and scientific departments to achieve client-ready reports and data transfers Professional Development - Attend meetings associated with Quality Control or the work of 360biolabs - Participate in training courses and seminars as related to the role ## Key Selection Criteria ## Qualifications - Bachelor of Science (Hons) or equivalent qualification plus relevant experience (Essential) ## Experience / Knowledge / Attributes - Experience in a quality-controlled laboratory environment (preferably ISO/IEC 17025) (Essential) - Knowledge of laboratory techniques & assays (Desirable) - Excellent organisational and writing skills (Essential) - Ability to work as part of a team (Essential) - Good communication skills (Essential) - High Attention to detail and a willingness to learn and ask questions (Essential) - Proficient in use of Word Office, including Word, Excel, and PowerPoint (Essential) - Experience with database software (Essential) - Experience in the conduct of early phase clinical trials (Desirable) - High motivation and enthusiasm for medical research, therapeutic and vaccine development (Desirable) Applications close on 10th November 2026 at 9:15AM.  Please submit your application via the job link if you're interested in joining us, as we’re not able to process applications sent by email. For further information, please contact our Careers Team (careers@360biolabs.com). Apply now if you have what it takes to join our team! 360biolabs is a flexible, equal opportunity employer looking for committed and like-minded people to join us. Our culture is something we are very proud of, celebrating each individual and everything they bring to our team. We encourage applications from Aboriginal and Torres Strait Islander people, all members of the LGBTQIA+ community and people with a disability. To learn more about how we collect, use, and protect your information, please review our Privacy Policy and Terms of Use. To express your interest in this position please submit a CV and cover letter. Applications only accepted from Australian / NZ residents with valid Australian work rights. #360biolabs ## About BioAgilytix ## Company Overview - **One-liner**: BioAgilytix is a global contract research organization providing GxP-compliant bioanalytical testing services to support pharmaceutical and biotech partners in all phases of drug development. - **Entity Type**: Private (funded) - **Headquarters**: Durham, North Carolina, United States - **Founded**: 2008 - **Founders**: Not publicly available ## Core Business - **Primary Industry**: Biotechnology Research / Bioanalytical Contract Research Organization (CRO) - **Target Customers**: B2B; specifically top pharmaceutical and biotechnology companies developing cutting-edge therapies. - **Mission or Purpose Statement**: To deliver innovative and reliable bioanalytical testing solutions, providing data and insight which lead to better, faster decisions on drug candidates in development. ## Products & Services BioAgilytix offers a comprehensive suite of laboratory services, primarily conducted under non-GLP, GLP, GCP, and GMP quality control testing: - **Pharmacokinetics (PK) Services**: Assay development, validation, and sample testing for small molecules, large molecules, and advanced drug modalities. - **Immunogenicity Services**: Screening, characterization, and neutralizing antibody assays to optimize drug safety, leveraging deep expertise in unwanted biotherapeutic-induced immunogenicity. - **Biomarker Analysis**: Fit-for-purpose biomarker assay development and testing from a menu of over 120 off-the-shelf assays, supporting clinical trial efficacy and safety. - **CMC Analytical Services**: Cell-based potency assays, molecular assays, mass spectrometry characterization, and other analytical methods supporting therapeutics from pre-IND to commercial release testing. - **Diagnostic Testing Services**: Offered at its CLIA-certified, CAP-accredited Boston laboratory. ## Market Standing - **Valuation/Market Cap**: Not disclosed (private company) - **Key Metric**: Annual Revenue of **$130M**; **$30.1M** in total funding from one prior round. - **Notable Investors/Partners**: Not specifically named in available sources. They support 21 of the world’s top 25 biopharma companies and supported ~30% of FDA-approved biologics from 2020 to 2024. - **Growth Signals**: - **1,100+ employees**, with a headcount growth of 2.1% YoY (+19 people) to 698 (according to LinkedIn, which may be lower than the company's self-reported total). - **Industry-leading employee retention rate of 90%**. - Global presence with labs in Durham, NC; Boston, MA; San Diego, CA; Hamburg, Germany; Melbourne and Brisbane, Australia; and partner labs in Beijing, China. ## Competitive Advantages - **World-Class Expertise**: Over 50% of scientists hold PhD and/or master’s degrees; the science team averages over 10 years of bench experience. - **Proven Track Record**: Supported ~30% of FDA-approved biologics between 2020 and 2024 and works with 21 of the top 25 global biopharma companies. - **Global Scale & Local Reach**: Operates in key biopharma hubs across the US, Europe, and Australia, with partner labs in China, enabling seamless global study transitions. - **High Retention**: A 90% employee retention rate indicates strong workplace satisfaction and internal stability. - **Comprehensive Capabilities**: Offers an "industry’s most complete set of capabilities," from assay development to commercial batch release, providing a consultative, scientist-to-scientist partnership model. ## Strategic Focus Based on available materials, BioAgilytix is focused on continued expansion of its global footprint (notably in Australia and Europe), deepening its expertise in advanced drug modalities (cell and gene therapies, oligonucleotides), and maintaining its leadership in bioanalysis for biologics. Its strategic focus is to proactively anticipate assay challenges to keep partner drug development timelines on track. ## Why Work Here - **Culture & Mission**: BioAgilytix fosters a culture of diversity, equity, and inclusion, supported by employee resource groups (ERGs). Employees solve "mission-critical bioanalytical solutions" that help bring therapies to patients faster. - **Work Policy**: Roles are **on-site** at specific lab locations (e.g., San Diego, CA; Melbourne, Australia; Durham, NC). This is a lab-based scientific organization. - **Benefits (US)**: Competitive compensation, health/dental/vision insurance, 401(k) savings plan, paid time off, paid parental leave, short- and long-term disability, group life insurance, employee assistance programs, adoption and fertility support, pet insurance, and legal assistance. - **Professional Development**: Access to high-visibility industry forums, continuous learning platforms, and opportunities to work on cutting-edge therapies for the world’s top pharma companies. ## Sources 1. [bioagilytix.com](https://www.bioagilytix.com/) 2. [bioagilytix.com - Careers](https://www.bioagilytix.com/about/careers/) 3. [bioagilytix.com - Corporate Brochure](https://www.bioagilytix.com/wp-content/uploads/2026/03/BioAgilytix-Corporate-Brochure-March-2026.pdf) 4. [linkedin.com](https://linkedin.com/company/bioagilytix) 5. 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