13 qa specialist jobs found in Rensselaer, NY

We are currently looking to fill a Quality Assurance Specialist position to support the Manufacturing Execution System (MES). This position will support a cross functional team of MES Specialists by providing a QA perspective with regards to manufacturing business processes, documentation requirements, and overall design of records. We are looking for someone who can continuously provide QA input and feedback in accordance with regulations, policies and procedures. In this role, a typical day might include the following: Reviewing company documentation including SOPs, SPECS, Process Transmittals, and Manufacturing Batch Records to assess MES impact Identifying difficulties and suggesting alternatives that are aligned with QA Reviewing MES change controls and test plans Working with Technical Trainers to develop QA training plans for MES users Collaborating in the creation, review, and approval of validation documents Reviewing and approving MES recipes, master...

We are currently looking to fill a Quality Assurance Specialist (Batch Disposition) position. This position performs activities supporting dispositioning product while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. In this role, a typical day might include the following: Review of data in LIMS to perform QC CofA review Review and approval of QC Virology CofAs Represent disposition in support of onboarding new modalities and product forms Assess change controls in support of LAF creation Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in, and/or ownership of, investigations, evaluations, and problem resolution Represents the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; collaborate closely with external partners and provide input on regulatory...

We are hiring a QA Specialist for our Technical Transfer Start Up Team (TTST). As a QA Specialist you will provide QA oversight in the TTST to ensure manufacturing documentation a nd implementation aligns with Process Transmittals and meet the requirements of Regeneron’s quality system. In this role, typical day may include: Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution. Train and/or mentor junior employees, including providing insights and education on processes and procedures. Provides consultation or advice in alignment with QA policies. Review, edit, or approve Regeneron controlled documents. Review and approval of investigations associated with raw materials, product, laboratory, facilities, and materials. Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement. Responsible...

We are currently looking to fill a Quality Assurance Specialist position. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. In this role, a typical day might include the following: Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution  Participate as a QA representative on Technology Transfer Startup Teams where responsibilities include providing guidance on QA procedures and polices as well as review of documents for both internal and external transfers Providing consultation or advice in alignment with QA policies Reviewing completed records and batch sheets and working with other departments and communicate internally (Tarrytown, Raheen) and externally...

We are currently looking to fill multiple Quality Assurance Specialist (Drug Product) positions. These positions will support Quality Assurance initiatives for a broad range of topics relative to the start-up and operations of a Drug Product facility. Available Work Schedules: Sunday-Wednesday, 1st shift (4x10) Monday-Thursday, 3rd shift (4x10) In this role, a typical day might include the following: Work on and potentially lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label team. Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug product operations; where current documents are not adequate, identify path forward for establishment of procedures Develop, write, review, and approve SOPs, specifications, and other documents. This includes documents for operation and facility SOPs, quality training, batch documentation, etc....

We are currently looking to fill a Principal Quality Compliance Specialist to join the Quality Assurance Change Control Business Process Team. The Quality Compliance Specialist ensures adherence to cGMPs , internal, external, and international requirements with respect to change control activities. This role is integral to facilitating process improvements, ensuring robust training for system end users, and supporting the Quality Management System.     As a Principal Quality Compliance Specialist, a typical day might include the following:   Developing and executing a comprehensive training strategy for the change control quality system.   Leading training for end users of the Change Control System.   Partnering with counterparts to Identify, Develop, and Implement Continuous Improvements to the Change Control System, Process and associated procedures.   Sponsoring and advocating for...

We are currently looking to fill a Sr QA Project Specialist role supporting our Change Control Business Process Management team. This position supports the achievement of Quality Assurance (QA) objectives by planning, coordinating and leading project activities. This position manages cross-functional projects as both a facilitator and organizer, using knowledge within the pharmaceutical industry and project management techniques. In this role, a typical day might include the following: Lead cross-functional projects and develop project timelines.   Identify and lead project priorities and cross-project dependencies.   Collaborat e with functional leads/subject matter experts in driving execution and removing constraints that prevent advancement of efforts/projects.   Proactively engag e in activities to meet schedules and resolve issues .   Identify skills needed for project management and deploy and...

We are currently looking to fill a QA Inspection Specialist position. This position will support Visual Inspection operations performed at Regeneron’s Internal Fill/Finish facility.  This position will provide floor support during production activities and also contribute to establishing/updating procedures and policies to ensure assigned areas are operating to current FDA and International Regulatory Body requirements.     Available Working Schedule: Monday-Friday, 2nd shift (2p-10:30p) In this role, a typical day might include the following: Oversee programs to support Visual Inspection Operations at the Drug Product facility. Ensure that facilities, equipment, materials, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other Regeneron controls. Execute daily operations, including, but limited to: Providing Quality Oversight and...

We are currently looking to fill multiple Quality Assurance Specialist positions. This position performs and leads activities “on the floor” in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. Available Work Schedules: Wednesday-Saturday - 1st shift Wednesday-Saturday - 2nd shift Wednesday-Saturday - 3rd shift Sunday-Wednesday - 3rd shift In this role, a typical day might include the following: Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution Represents the organization on behalf of QA with external partners to communicate QA policy and procedures; liaise with external partners and provide input on regulatory communication Train and/or mentor employees, including...

We are currently looking to fill a Senior Quality Compliance Specialist, Quality Assurance position on the Quality Assurance Change Control Team.   This role works within the QA Change Control Team to facilitate partner relationships and oversee operational activities regarding partner change notifications. As a Senior Quality Compliance Specialist, Quality Assurance, a typical day might include the following: • Acting as Regeneron’s representative in meetings with external Partners to discuss changes for applicable products • Participating in internal cross functional teams on global change management of partnered products • Sponsoring and advocating for Continuous Improvement activities and working with other members of the Quality Assurance team and/or end users of the system on the development and implementation of updates to the Change Control Partner Notification Process and associated procedures • Developing relationships with end users and providing advice on best...

The QA Validation Fill Finish team is hiring a Manager! As the Manager, QA Validation you will validate/qualify equipment, systems, and processes related to cleaning, sterilization, and Aseptic Process Simulation Validation in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. In this role, a typical day may include: L eads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods, and other industry practices. Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and being responsible for Validation projects as well as junior-level staff. Based on engineering specification, performs validation projects which include authoring protocols, implementing validation protocols, and writing reports of validation...

We are currently looking to fill a Manager, QA (Supplier Quality) position. This position coordinates the Quality Assurance initiatives for a broad range of topics relative to material and supplier quality including Supplier Management and Material Qualification. This role also supervises a team of Material Supplier and Compliance Specialists.   In this role, a typical day might include the following: ·        Accomplishes material and supplier quality objectives through team members and by planning and evaluating area activities. ·        Track status of quality records including document workflows (SOPs, material specifications, etc.), change controls, deviations, CAPAs, extensions, and SCARs. ·        Defines and implements quality standards, systems, and metrics for clinical and commercial operations. ·        Preparing and completing action plans while implementing productivity and quality. ·        Resolving problems,...

We are currently looking to fill a Manager, Process Validation Oversight position. This leads a department responsible for the oversight of qualification of the equipment, systems, and processes validation for our Contract Manufacturing Organizations (CMOs) and partner groups in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.   In this role, a typical day may include: ·          Leads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods, and other industry practices. ·          Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and overseeing Validation projects as well as junior-level staff.  Based on engineering specification, performs validation projects which include authoring...