- Merck & Co. (Durham, NC)
- …a hands-on approach to problem solving, and be self-motivated to identify and lead process improvement projects.The Quality Assurance Specialist provides ... IS Audit, Multidisciplinary Collaboration, Problem Solving, Process Improvement Projects, Process Simulation, Quality Assurance ( QA ), Quality … more
- Formation Bio (New York, NY)
- …efficiently.About the PositionWe are seeking a highly accomplished, strategic Vice President of Quality Assurance . In this pivotal role, you will have the ... the strategic development and operational management of Formation Bio's quality assurance program to support the growing...and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the… more
- Cipla (Fall River, MA)
- … in a cGMP pharmaceutical manufacturing operation environment. Current, working knowledge of quality assurance ( QA ). Strong knowledge and experience with ... Job Title : Quality Assurance Operation Specialist FLSA Classification...and associated controls during the batch run. Act as quality lead for all shop floor questions… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Clinical Quality Assurance Professional (QAP) position is responsible for design, delivery and execution ... of the global Clinical Quality Assurance (CQA) strategy including audit and...as a part of that plan.Champion CQA's mission of ' Quality as enabler of business'; lead global… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, and ... through Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including… more
- Aequor (Thousand Oaks, CA)
- …System organization. Under general supervision, provide tactical support activities to Quality Management System Lead . Specific responsibilities include but are ... Senior Specialist QA Remote any time zone OK Benefit but...Does the thought of building an entirely new digital quality management system, excite you? Do you love to… more
- Cipla (Fall River, MA)
- …with established specifications and standard operating procedures (SOPs). JOB DESCRIPTION The Quality Assurance ( QA ) Inspector position is an individual ... Job Title : QA Manufacturing Inspector - On-the-floor Inspector FLSA Classification...(May vary based on business needs) Reports To : Quality Assurance Manager Salary Range : $21… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. ... Role OverviewThe QA Investigations Lead is responsible for providing quality oversight...experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality… more
- Cipla (Central Islip, NY)
- …General: 8:30AM - 5:00PM (may vary based on business needs) Reports To: Quality Assurance Manager Purpose: This position requires a strong analytical ... outside of Cipla's US Subsidiaries or Affiliates. Job Title: QA Associate II AQA FLSA Classification: Professional, Exempt Work...are not limited to the following: Scope: The Analytical Quality Assurance (AQA) associate II O III… more
- Cipla (Central Islip, NY)
- …reports, including root cause analysis and corrective actions. Work closely with QA , AQA, operations, quality control, and other departments to gather ... Job Title QMS Lead - Investigations Organization Name InvaGen Pharmaceuticals, Inc....systems to ensure they do not negatively impact product quality . Conduct risk assessments for proposed changes and implement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic collaboration with other GxP Quality representatives, and act as the Quality Assurance point person for all GxP matters within the Medical Affairs ... with Medical Affairs leaders to assign tasks to remove those gaps. - Provide operational QA leadership and Quality Oversight for the Quality Plan execution,… more
- Cipla (Hauppauge, NY)
- …employees working outside of Cipla's US Subsidiaries or Affiliates. Job Title : QA Validation FLSA Classification : Professional, Exempt Work Location : Unit 1, ... General: 8:30AM - 5:00PM (may vary based on business needs) Reports To : QA Validation Manager Salary Range: $68,000 - $74,600 Purpose: The incumbent to this role… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …electronic quality systems and SAP.Contribute to the improvement of QA practices to ensure accurate documentation activities, including manual and electronic ... in the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Specialist II/III as part of the... Batch Disposition Specialist II/III as part of the Quality team based in Raritan, NJ. Role OverviewThis exempt-level… more
- Merck & Co. (Rahway, NJ)
- …ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The ... and finalization, and feed to the Submissions Assembly team. The Business Operations Lead should be able to understand the various source area processes and apply… more
- Merck & Co. (Millsboro, DE)
- …requirements as they apply to the biologics field or a related area - Quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas- - ... Job DescriptionThe Senior Quality Specialist ensures product/process quality system adherence and batch record review, completes quality checks and SAP… more
- Insmed Incorporated (NJ)
- …across Patient Services. Lead audit readiness and inspection management for internal QA , client, and regulatory audits, including regular quality reviews with ... of science, we're in. Are you?About the Role:The Associate Director, Patient Services Quality & Process leads quality assurance and process improvement… more
- Merck & Co. (Rahway, NJ)
- …improvement plans.Support contract reviews, amendments and renewals with procurement and legal. Lead customer communications and quality assurance for ... Associate Director will own the vendor relationship for our contact center partner, lead QA and coaching programs, run data-driven outreach campaigns, and ensure… more
- BioAgilytix (Durham, NC)
- …for data quality , access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory ... LIMS and ERP systems.Proven ability to define data standards, develop and implement quality assurance processes, and ensure data integrity in alignment with… more
- Cipla (Fall River, MA)
- …collaborating with Cipla global stakeholders particularly Integrated Product Development (IPD) and Quality Assurance ( QA ) to incorporate technical best ... portfolio, R&D technical staff, supply chain management, medical affairs, regulatory affairs, quality assurance , procurement etc. Act as the custodian of the… more
- Merck & Co. (Millsboro, DE)
- …(freeze-drying) capacity being built at the site.This role is the Technical Lead for Lyophilization with both deep scientific experience and practical commercial ... manufacturing judgment. You will lead technical strategy, science-based technology transfer and scale-up of freeze-drying and fill-finish processes for vaccine and… more
