Current jobs related to Specialist, Quality Assurance for QC - Sanford - Astellas
-
QC Production Associate I
4 days ago
Sanford, United States SOFIE Full timeJoin our team as a QC/Production Associate I, where you'll play a key role in producing life-changing drug products and ensuring their quality through hands-on work with advanced radiosynthesizers and analytical equipment.QC/Production Associate ITitle | QC/Production Associate IDepartment | Network OperationsReports To | Facility ManagerOverviewThe...
-
QC Production Associate I
7 hours ago
Sanford, United States SOFIE Full timeJoin our team as a QC/Production Associate I, where you'll play a key role in producing life-changing drug products and ensuring their quality through hands-on work with advanced radiosynthesizers and analytical equipment.Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.QC/Production...
-
Specialist III, Quality Assurance Operations
1 week ago
Sanford, United States Kyowa Kirin Full timeAccelerate Your Career With Kyowa Kirin North AmericaBe a part of Kyowa Kirin's growth story. It's life-changing work. Explore opportunities to join our team and see our open roles.Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need:...
-
Specialist III, Quality Assurance Governance
2 weeks ago
Sanford, United States Kyowa Kirin Full timeKyowa Kirin North AmericaKyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need: oncology, nephrology, immunology, and CNS/movement disorders. The North American organization includes two offices (in New Jersey and California) that focus on...
-
Pharmaceutical QA Senior Specialist
2 days ago
Sanford, United States Eurofins PSS Insourcing Solutions Full timePharmaceutical QA Senior Specialist - Group Leader Eurofins Scientific is an international life sciences company, providing a range of analytical testing services to clients across multiple industries. Our mission is to make life and the environment safer, healthier, and more sustainable. We work with major companies worldwide to ensure product safety,...
-
Quality Assurance Associate
2 days ago
Sanford, United States Belcan Corporation Full timeDirect message the job poster from Belcan Keyword's: #Sanfordjobs; #AssuranceAssociatejobs. Start Date: Immediate Job Description: Responsibilities and Accountabilities Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry...
-
Pharmaceutical QA/QC Senior Specialist
2 days ago
Sanford, United States Eurofins PSS Insourcing Solutions Full timeEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier, and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest...
-
Quality Assurance Associate
2 days ago
Sanford, United States Pfizer Full timelocations United States - North Carolina - Sanford time type Full time posted on Posted Today job requisition id 4936811 Use Your Power for Purpose Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always...
-
Quality Assurance Associate
2 days ago
Sanford, United States SGS Consulting Full timeBase pay range $50.00/yr - $80.00/yr Job Description The Role The Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing, Quality Control, Facilities, and...
-
Quality Assurance Senior Associate
3 days ago
Sanford, North Carolina, United States Pfizer Full timeUse Your Power for PurposeEvery day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your...
Specialist, Quality Assurance for QC
2 weeks ago
Specialist, Quality Assurance for QC Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com. Purpose and Scope: The Specialist, Quality Assurance for QC will be responsible for providing direct Quality oversight and support for Quality Control and US Methods and Tech Transfer laboratory operations and method qualification activities. This role will ensure adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This role will collaborate with cross-functional teams such as other Quality Assurance, Validation, Manufacturing, and MSAT teams to ensure quality and compliance. Essential Job Responsibilities: Quality Oversight of Laboratory Operations: Provide QA oversight of QC laboratory activities, including testing of raw materials, in-process samples, drug substance and drug product, and environmental monitoring. Conduct routine area walkthroughs to ensure laboratories operate in a state of control and comply with current Good Manufacturing Practices (cGxP). Test Method and Material Lifecycle Management: Oversee the qualification, validation, and transfer of analytical methods, critical reagents, and reference standards. Review and approve associated protocols, reports, and deviations to ensure compliance with regulatory and internal standards. Technical Leadership and Support: Serve as a Subject Matter Expert (SME), providing advanced technical guidance and troubleshooting support for complex laboratory and quality-related issues. Make informed decisions with minimal guidance, proactively seeking input when addressing cross-functional challenges. Assist in workload management by prioritizing and distributing tasks across the team to ensure efficient execution of responsibilities. Data and Documentation Review: Review and authorize laboratory testing data within Laboratory Information Management Systems (LIMS). Review and approve Certificates of Analysis (CoA) and Certificates of Testing (CoT) to support batch disposition. Review and approve Product Specification documents to ensure alignment with regulatory and internal requirements. Quality Systems and Compliance: Lead or support nonconformances and deviations related to QC processes, including laboratory investigations, Out of Specification (OOS), and Out of Trend (OOT) results. Author, review, and approve controlled documents such as Standard Operating Procedures (SOPs), specifications, protocols, and reports for Quality and GMP-related functions. Author, review, and approve Quality System records, including Nonconformances, Corrective and Preventive Actions (CAPAs), and Change Management documentation, with thorough causal and impact assessments.
