Sigma
Quality Assurance Associate Specialist
The Quality Assurance Associate Specialist role ensures product batches meet regulatory and quality standards before release. This role involves the release of batches, creation of CoAs, audit support and close collaboration with production teams to resolve any issues. Responsibilities: Ensuring the adherence to safety and quality regulations, specifications, and policies to enable strong delivery to the customer. Align quality capabilities with customer expectations, ensuring products meet not only compliance requirements but also specific customer demands for quality, customization and crucially the overall customer experience. Utilizing an operational mindset to standardize global test methods and drive efficiencies by optimizing key processes such as capacity planning, performance management and consumables management. Foster a collaborative approach between production, engineering and quality to drive shared ownership of quality outcomes and upskill production operators and process engineers in quality requirements and processes to facilitate in-process testing, process optimization and autonomous decision making. Excel in understanding and ensuring products meet and maintaining thorough documentation for audits and inspections. Quality standards and regulatory requirements. Minimum Qualifications: High School Diploma or GED. 1+ years of life science industry experience. Preferred Qualifications: Knowledge of ISO 9001 and ISO 13485 and regulatory compliance issues (i.e., FDA, USDA, ICH, EDQM, IVDR) related to biologic derived materials, and prior experience working in a controlled/regulated environment. Current fine chemical industry knowledge &/or experience. Good computer skills, including proficiency in MS Word, MS Excel, MS Access, MS Project, MS PowerPoint, and ability to learn and operate using other specific application software (SAP, Trackwise, etc.). Communication (verbal & written) and customer services skills. Experience writing technical documentation & reports. Ability to simultaneously manage multiple tasks/priorities. Good problem-solving skills/abilities. Good time management and negotiating skills. Capacity for independent work. We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
The Quality Assurance Associate Specialist role ensures product batches meet regulatory and quality standards before release. This role involves the release of batches, creation of CoAs, audit support and close collaboration with production teams to resolve any issues. Responsibilities: Ensuring the adherence to safety and quality regulations, specifications, and policies to enable strong delivery to the customer. Align quality capabilities with customer expectations, ensuring products meet not only compliance requirements but also specific customer demands for quality, customization and crucially the overall customer experience. Utilizing an operational mindset to standardize global test methods and drive efficiencies by optimizing key processes such as capacity planning, performance management and consumables management. Foster a collaborative approach between production, engineering and quality to drive shared ownership of quality outcomes and upskill production operators and process engineers in quality requirements and processes to facilitate in-process testing, process optimization and autonomous decision making. Excel in understanding and ensuring products meet and maintaining thorough documentation for audits and inspections. Quality standards and regulatory requirements. Minimum Qualifications: High School Diploma or GED. 1+ years of life science industry experience. Preferred Qualifications: Knowledge of ISO 9001 and ISO 13485 and regulatory compliance issues (i.e., FDA, USDA, ICH, EDQM, IVDR) related to biologic derived materials, and prior experience working in a controlled/regulated environment. Current fine chemical industry knowledge &/or experience. Good computer skills, including proficiency in MS Word, MS Excel, MS Access, MS Project, MS PowerPoint, and ability to learn and operate using other specific application software (SAP, Trackwise, etc.). Communication (verbal & written) and customer services skills. Experience writing technical documentation & reports. Ability to simultaneously manage multiple tasks/priorities. Good problem-solving skills/abilities. Good time management and negotiating skills. Capacity for independent work. We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!