- Merck & Co. (Rahway, NJ)
- …inspections. Independently performs audits of batch documentation, data, information, procedures , equipment and systems, and/or facilities to ensure the compliance ... with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable...(GMPs) and other applicable worldwide regulations and our Company procedures .- The Senior Specialist will become knowledgeable in regulatory… more
- Merck & Co. (Millsboro, DE)
- …temporary employees or other departmentsReview and revise processes and procedures against corporate and regulatory policies.Review production records for ... completeness and compliance to departmental and/or Site Standard Operating Procedures (SOPs).Provide training to personnel to stay current with all regulatory… more
- Aequor (Athens, GA)
- …and Teaching, BI AH policies and Veterinary Sciences standard operating procedures , and the fundamental requirements for AAALAC accreditation. In addition, this ... individual assists with scientific procedures in accordance with study protocols, completes and maintains appropriate documentation associated with all job… more
- Aequor (Hicksville, OH)
- …Participates in training of new employees. Adheres to all applicable procedures , cGMP's, company policies, and all other quality or regulatory requirements ... (BBSP) by complying with and assuring personnel are following all safety procedures (LOTO) and preventive measures (ie, wearing Personal Protective Equipment (PPE),… more
- Aequor (Hicksville, OH)
- …inventory adjustments. Major Accountability: Possesses required knowledge of SOP's, cGMP's, procedures , SAP entries and has the ability to explain the requirements ... required paperwork. Performs other duties as assigned Adheres to all applicable procedures , cGMPs, company policies and any other quality or regulatory requirements.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: This position oversees ICSR Standards activities, projects, and procedures . This level interacts within global CSPV and with CROs, vendors, ... oversight to manage relationship with CROs and Vendors.Case Processing Policies and Procedures : Reviews, approves, provides input on and authors SOPS, SOIs, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and marketed products; required4 or More Years Knowledge of Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP) required4 or More ... and safety databases; preferred4 or More Years Familiarity with Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP), PharmD, RN, or… more
- Merck & Co. (Durham, NC)
- …tasks, resolves deviations and evaluates equipment performance.- Follows proper procedures for maintaining production equipment in a clean room environment. ... safe maintenance and repair of equipment using Hazardous Energy Control Procedures (HECPs)Compliance with current good manufacturing procedures (cGMP), safety and… more
- Merck & Co. (Durham, NC)
- …tasks, resolves deviations and evaluates equipment performance.- Follows proper procedures for maintaining production equipment in a clean room environment. ... safe maintenance and repair of equipment using Hazardous Energy Control Procedures (HECPs)Compliance with current good manufacturing procedures (cGMP), safety and… more
- Tris Pharma (Monmouth Junction, NJ)
- …(ST) samples for pilot and submission batches, according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) procedures . The ... Practices (cGDPs), cGMPs and SOPs Evaluates compendial methods and procedures , as neededPrepares regulatory submissions; Executes studies and prepares technical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …knowledge of relevant industry standards and regulations, and company policies and procedures relevant to his/her area of work Provides support to other functional ... Manage the application and communication of all Novo Nordisk policies, procedures , and Novo Nordisk Way. Qualifications Education Level: Minimum Bachelor's degree… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Inc. (NNI). Assignments are objective oriented. Establishes operating policies and procedures that affect the work unit. Develops budgets, schedules, and performance ... pre-call planning in preparation for customer visits Communicates NNI policies, procedures (including 3P - setting/reviewing annual goals) and organizational changes… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …clients. This individual will need to train and follow standard operating procedures and work instructions and comply with cGMP regulations and safety guidelines.Key ... forwarders, receiving parties, and internal clients. Train and follow standard operating procedures and work instructions and comply with cGMP regulations and safety… more
- Aequor (Cincinnati, OH)
- …Loading/unloading scientific glassware in dishwasher according to written procedures Handwashing glassware Inspection of glassware following cleaning to ... Perform inspection of house cleaning checklist weekly Monitor and implement safety procedures as part of lab safety committee Perform routine and non-routine… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …position requires strict adherence to cGMPs, established manufacturing practices and procedures , and compliance with quality regulations and guidelines. The Front ... Perform area equipment and process validations in accordance with validation procedures Perform in-process product testing in accordance with standard procedures… more
- Repligen (Anaheim, CA)
- …stainless valve components.ResponsibilitiesFollow detailed manufacturing and assembly procedures .Follows process order requirements for assembly and ... and power tools to assemble productsTrain new personnel on manufacturing procedures .Communicate all pertinent information and advise direct Supervisor of any… more
- Merck & Co. (Rahway, NJ)
- …all staff members are adequately trained and practice safe operating procedures in support of requirements.Ensure compliance (Safety, Health, Environmental, GxP (as ... DOT, Labor, HR, etc.) for all applicable company protocols, practices, procedures , and regulatory requirements.Coordinate with outsourced service providers to d… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …performs audits, identifies compliance issues and trends, reviews systems and procedures .Ensure trending and signal detection is communicated to stakeholders for ... GxP related regulations / guidelines (eg, FDA, EU, ICH) and company procedures and policies. Competencies:Professional or other related function and familiarity with… more
- Aequor (East Syracuse, NY)
- …/ Responsibilities Develop, author, and peer review standard operating procedures , analytical methods, protocols, reports, and other associated scientific technical ... preparation and review of regulatory submissions related to analytical procedures , method development and validation, specifications, reference standards, extended… more
- Merck & Co. (Rahway, NJ)
- …work efficiencies, and cost reduction opportunities.Manage documentation, Standard Operation Procedures , and internal Standards for Technology Space products and ... and train other Technology Space staff on best practices, processes, and procedures .Use our DCIM tool Sunbird to document, design, and plan IT equipment… more
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