- Exela Pharma Sciences, LLC (Lenoir, NC)
- …This position will additionally serve as a final Quality Reviewer/Approver for internal documentation. The Documentation Control Supervisor is also responsible ... Position SummaryThe Documentation Control Supervisor is responsible for overseeing the Documentation Control Unit as it pertains to processing of master… more
- Merck & Co. (Rahway, NJ)
- …integrated audits and process audits, both domestic and abroad to maintain a strong internal control environment at our Company.Under the direction of the AIC, ... execution of the company's strategy; this includes a deeper knowledge of internal controls, business compliance, and risk management. Individuals will be based in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …training, CVs, JDs- Collect, store and maintain all auditable documentation as per DSI Internal control - Support the Head Global QA strategy and operations to ... for meetings and a wide array of audiences- Edits and produces advanced internal and external communications; acts on behalf of an executive for certain decisions… more
- Daiichi Sankyo, Inc. (Seattle, WA)
- …PHI appropriately by ensuring compliance with HIPPA regulations, laws and internal company guidelines. Control business expenses related to field activities ... of DSI products. ADFR's provide strategic coverage/reimbursement leadership and support to internal DSI leadership and Care Team's to which their geographies align.… more
- Merck & Co. (Millsboro, DE)
- …of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create ... of the Director of Quality, the Associate Director, Quality Control is responsible for leading all Quality Control...the QC team and with other site and company internal /external stakeholders, including a culture of open communication and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Operations Inventory Control Specialist as part of the Technical Operations team based in Raritan, ... New Jersey. Role OverviewThe Operations Inventory Control Specialist will be part of the Raritan CAR-T Operations team responsible for building operations activity… more
- Insmed Incorporated (San Diego, CA)
- …paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management Manager, ... and CMOs, Material Management, and other functions to ensure internal timelines, testing TAT, and team milestones are achieved.Create,...locations. Act as the single point of contact to control distribution of all samples for release and stability… more
- Aequor (Thousand Oaks, CA)
- …accuracy. Job Summary This position is a unique opportunity to work within Quality Control at the Thousand Oaks site and to directly support both manufacturing and ... Quality Control operations. Under minimal supervision analyze environmental monitoring samples,...investigation of out-of-specification and/ or non-conforming test results. Supports internal and external inspections and audits as needed (lab… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. We are currently seeking a Global Internal Audit Intern for the year (June 2025 - May 2026). This part time ... annual audit plan and JSOX testing as directed by the leader of Internal Audit which consists of:Executing of Financial, Operational, Compliance and Process audits… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is primarily responsible for budgeting and forecasting, analysis, strategic planning, internal reporting, ad hoc reporting and analysis, and change management ... initiatives. Also responsible for expense or headcount control procedures and management reporting capabilities. Develops and maintains a working relationship with… more
- Merck & Co. (Rahway, NJ)
- …addition, the CCQMs support audits, inspections as well as Quality Control and local training activities.-Qualifications: Bachelor's Degree or equivalent in relevant ... teams. Ideally, experience in Clinical Quality Management including Quality Control Activities, Process Management & Improvement. Ideally, experience in managing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with senior leadership and will play a role to integrate OEDC with internal scientific and functional line areas as well as externally with OEDC stakeholders, ... both internal and external. This role will assist the OLT...and compliance of all required DS documentation for quality control /assurance, legal, finance, operational and educational requirements.Operates at a… more
- Merck & Co. (Rahway, NJ)
- …primary role of the candidate will be to participate in the execution of IT internal audit engagements to assess the adequacy of internal controls. This includes ... to provide reasonable assurance that adequate application and infrastructure internal controls are both designed and operating effectively.--A successful incumbent… more
- Eisai, Inc (Nutley, NJ)
- …risk assessments.Establish IT security risk assessment framework and compliance control framework.Oversee global IT compliance training programs.Support regional IT ... Assessment: Create and periodically assess a global IT compliance risk framework. Control Gaps: Identify and manage IT compliance control gaps.Monitoring… more
- Merck & Co. (Rahway, NJ)
- …process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process ... direction of Director in the CCFS group and working in conjunction with internal and external partners, this individual will support late stage and commercial large… more
- Merck & Co. (Rahway, NJ)
- …and other parts of the AR&D organization in aspects of quality control and compliance. Your main responsibilities will include: - Strategy and Operational ... maintaining open and active communication. Defining and implementing operational control strategies to ensure efficient GMP processes while maintaining high-level… more
- Merck & Co. (Rahway, NJ)
- …This role involves leading the method tech transfer strategy and execution to internal and external GMP testing nodes in support of clinical and PPQ supplies. ... (PSS), and Design Verification (DV).Lead method tech transfer strategy and execution to internal and external GMP testing nodes in support of clinical and PPQ… more
- Merck & Co. (Rahway, NJ)
- …The incumbent may also be part of the team providing Quality oversight of internal inspection preparedness and performance of internal audits. The role could ... with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and regulatory requirements; OR… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position also works on statistical methodology and leads/contributes to internal statistical workstreams to address various project needs. The position works ... research organization (CRO) programmers and statisticians and collaborates with internal programmers in preparing analysis files and performing statistical analyses.… more
- BioAgilytix (Durham, NC)
- …all phases of our client services. You will be the glue connecting our internal functions to the actions required of an efficient and quality-driven project process. ... you'll be right at home here at BioAgilytix.Essential ResponsibilitiesPartner with internal and external stakeholders to define and monitor project timelinesEnsure… more
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