- Merck & Co. (Durham, NC)
- …deliverables related to the vaccine process Lead technical studies and author documentation associated with site commercialization efforts Participate in the ... analytics methodologies, including statistical process control, deepening process understanding Author , review, and/or edit technical documents to support regulatory… more
- Merck & Co. (Rahway, NJ)
- …equipment integrated processes such as ultrasonic welding and vision inspection systems. Author technical content of assembly process FMEAs to capture patient and ... (FAT) and report project progress, risks, and mitigations to the team. Author protocols, reports, create drawings and specifications to ensure proper documentation… more
- Insmed Incorporated (San Diego, CA)
- …batch records, SOPs, raw material specifications, protocols and author development reports.Demonstrated experience with process validation and scale-down ... situations or data requires an in-depth evaluation of variable factors. Author Standard Operating Procedures, technical reports, process descriptions, including data… more
- Merck & Co. (San Francisco, CA)
- …minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or co- author strategic documents. - Associate Directors are expected ... to have or be developing expertise in several areas, including: - Responsible for achieving results on major program drivers by implementation of one or more novel quantitative approaches that seek to improve cycle time, cost/size, number of trials, clinical… more
- Merck & Co. (Rahway, NJ)
- …equipment are maintained and are suitable for both GMP and developmental use.- Author , review and approve GMP procedures and documentation, with an emphasis on ... Qualification and Validation plans around equipment, critical utilities, and computer systems.- Prepare and approve qualification protocols and summary reports.- Execute qualifications, validation, commissioning, and decommissioning activities.- Prepare… more
- Merck & Co. (Rahway, NJ)
- …quality audits and maintain laboratory state of permanent inspection readiness Author or contribute to Standard Operating Procedures (SOP) draftingOriginate and own ... Investigations and Change Management recordsThe successful candidate must function both independently and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Strong communications skills and eagerness to adapt and learn are… more
- Merck & Co. (Rahway, NJ)
- …in his/her area of responsibility.To accomplish these goals, the Director may: Author detailed development documents, presentations, budgets, and position papers for ... internal and external audiencesFacilitating collaborations with external researchers around the worldTravel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.RequiredM.D or MD/Ph.D.Minimum 3 years… more
- Aequor (Tampa, FL)
- …Develops and executes validation protocols for test methods and equipment qualification. Author and review SOPs and test methods related to microbiology. Ensure the ... microbiological integrity of environment, equipment and facilities. Manages product testing based upon internal and customer specifications. Managing 3rd party laboratory testing and reporting of data and EM when necessary. Report on testing results, including… more
- Merck & Co. (Rahway, NJ)
- …on cross-functional teams to foster collaboration and innovation.Document Excellence: Author regulatory and technical documentation, ensuring all processes align ... with our company's expectations.Mentor Future Leaders: If you have a knack for leadership, you will also manage a small team of junior staff, guiding them in their professional development.What We're Looking For:Education:A degree in Biological Sciences,… more
- Merck & Co. (Rahway, NJ)
- …on opportunities to improve building flexibility, efficiency, compliance, and safety. Author lessons learnt and summary reports to capture knowledge gained.Mentor ... and help train rotational and new employees.This position's primary focus is executing batch production work. Additional responsibilities include coordination, planning, documentation, and other facility improvement activities. Position Qualifications:… more
- Merck & Co. (Rahway, NJ)
- …on opportunities to improve building flexibility, efficiency, compliance, and safety. - Author lessons learnt and summary reports to capture knowledge gained. - ... Mentor and help train rotational and new employees. - This position's primary focus is executing batch production work. Additional responsibilities include coordination, planning, documentation, and other facility - improvement activities. Position… more
- Twist BioScience (South San Francisco, CA)
- …reflects regulatory requirements and product specifications.What You'll Be Doing Initiate, author , and maintain Safety Data Sheets (SDS) for all Twist products, ... ensuring compliance with global regulations. Collaborate with cross-functional teams to obtain necessary product composition data and hazardinformation for accurate SDS generation. Manage the review, approval, and distribution of SDS to internal and external… more
- Formation Bio (New York, NY)
- …CMC activities comply with global regulatory expectations (eg, FDA, EMA, ICH); author and review regulatory submissions including INDs, BLAs, and other key ... documents. Continuous Improvement Stay current with emerging technologies, regulatory changes, and industry best practices; drive continuous improvement across all CMC operations. About YouRelevant Experience 10+ years of experience in the biopharmaceutical… more
- USAA (Phoenix, AZ)
- …intelligence sources (eg suppliers, peer financial institutions, information-sharing groups). Author and optimize processes for the analysis and treatment of ... fraud threat intelligence. Identify new tools, suppliers, and data sources to improve analysis capabilities. Grow the teams network of internal and external contacts to support intelligence sharing and fraud risk mitigation. We offer a flexible work… more
- Sun Life Financial, Inc. (Wellesley Hills, MA)
- …and refined product backlog that supports the company's goals and objectives Author feature briefs and user stories, conduct acceptance testing and create detailed ... experience using tools such as Jira to create user stories and author product documentation on Confluence. Collaborative and influential in your approach,… more
- Fair Square (Atlanta, GA)
- …long-term scalability and platform strategies. Solution Design & Documentation Author robust business and technical documentation including workflow diagrams, API ... interaction models, systems integration points, and test case outlines. Identify dependencies and gaps across systems and teams, ensuring cohesive implementation plans. Delivery Oversight Actively participate in Agile ceremonies (planning, stand-ups, grooming,… more
- Synergy America, Inc. (Lawrenceville, GA)
- …detailed solicitation requirements and content. *Facilitate business requirements gathering and author the artifacts from that effort such as Business Requirements ... documentation to Office of Strategic Excellence, Finance, and Project Management Office. * Author business cases in support of new technology that includes financial… more
- Rosewood Hotel Group (New York, NY)
- …implementation. *Liaise with third party partners and vendors to drive and author scope and process documentation. *Responds to evolving business needs with agility, ... ensuring analytics deliverables are completed at the pace of business with quick turnarounds. Reporting and Visualization: *Create, maintain and deliver regular reports and dashboards helping teams understand opportunities and track progress against key… more
- Shake Shack (Novi, MI)
- …created by Danny Meyer, Founder and CEO of Union Square Hospitality Group and best-selling author of Setting the Table. Shack Fans lined up daily, making the cart a ... resounding success, and donating all proceeds back to the park beautification efforts. A permanent stand was eventually built and the rest is Shack history! With our roots in fine dining and giving back to the community, we are committed to high quality food… more
- Collabera (New York, NY)
- …and contribute to long-term remediation strategies - requirements, etc. Author and maintain control documentation, including data flow diagrams, reconciliation ... procedures, exception handling protocols, filter and rule inventory used in surveillance systems Support internal audits and reviews by independent testing teams, providing accurate documentation, artifacts, and data. Job Requirement process documentation… more
