A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
Quality Control Compliance Lead at Hartmann Young Quality Control Compliance Lead at Hartmann Young in Albany, New York Posted in 4 days ago.
Type:
full-time
Job Description:
Quality Control Compliance Lead - CDMO Hartmann Young is partnered with a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotechnology companies to support the development, manufacture, and delivery of therapies for patients. We are looking for a QC Compliance Lead to join the team in Albany, New York. The Role In this role, you will support laboratory compliance, investigations and continuous improvement within a pharmaceutical manufacturing environment. You will also lead root cause investigations, oversee QC compliance activities and ensure laboratory quality systems remain inspection-ready. You'll work across laboratories, testing raw materials, chemical intermediates, APIs and stability samples, applying your expertise in analytical chemistry and quality systems. You'll also: Collaborate across teams to establish effective investigation approaches that support customer expectations and business priorities; Communicate investigation progress, findings and outcomes to key stakeholders and senior management; Analyse and trend QC laboratory data and performance metrics to identify recurring issues and areas for improvement; Work closely with QC leadership to address emerging themes and systemic risks, implementing sustainable improvements where required; Review and enhance analytical methods, procedures and training materials to support consistent laboratory performance; Identify opportunities to challenge and improve existing processes, introducing more efficient and effective ways of working. The Person Bachelor's Degree in Chemistry or related field; Minimum of 6 years' experience in a QC laboratory environment OR equivalent combination of relevant education and experience may be substituted as appropriate; Investigations experience including root cause analysis, writing, and CAPA identification; Strong knowledge of cGMP, FDA and international regulations, quality systems and applicable API pharmaceutical requirements, including relevant ICH guidelines. We're looking for someone with a good understanding of pharmaceutical manufacturing processes and laboratory operations, with excellent communication, influencing and stakeholder management skills. Ideally, you'll be highly organised, with strong time management and prioritisation skills, and the ability to manage multiple projects and deadlines independently. You'll be comfortable interpreting technical procedures, regulatory guidance and scientific literature, and translating requirements into clear actions and documentation. If this sounds like you, please apply here or reach out on ellen.stanton@hartmannyoung.com - we'd love to hear from you! Please note - relocation support is available for this position.
