- 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)
- …of responsibility. To accomplish these goals, the Senior 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. Education MD or MD/Ph.D. Required… 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
- 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
- Experis (New York, NY)
- …(Foreign Exchange, Commodities, and other Asset Classes). Proven ability to author comprehensive BRDs, user stories, and acceptance criteria. Proficiency with ... AI use cases such as credit memo automation and document extraction. Author and maintain Business Requirements Documents (BRDs), user stories, and acceptance… more
- First Choice Staffing Group (Syracuse, NY)
- …grammar, and discuss any problems and possible solutions with the author . Compile information; preparing and distributing forms and documents; answering questions ... orally or in writing and looking up inforn1ation Process forms, screen documents, maintain files and keep records in order to meet the requirements of agency programs. Work is accomplished in accordance with applicable procedures, rules, regulations and laws.… more
- Shake Shack (Los Angeles, CA)
- …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
- RER Solutions, Inc. (Washington, DC)
- …products on innovative energy technologies to educate private entities on client products Author policy white papers to help establish client viewpoint on how to ... execute a viable US commercialization pathway for specific energy technology verticals Support coordination of follow-on actions with internal and external stakeholders to advance client objectives Identify upcoming relevant events and ensure perspective is… more
- New America (Washington, DC)
- …social media amplification. Secondary duties (25%): Blog Writing & Presentations : Blogs: Author and/or co- author with supervisor or other analysts clear and ... compelling blog articles detailing effective capacity-building best practices, lessons learned, and college impact profiles drawing on Accelerator web workshop presentations, interviews with college leaders, light quantitative analysis (eg assembling and… more
- Endo International (Horsham, PA)
- …upgrades, addition of new equipment, and capital engineering projects. Author change management and other documentation for manufacturing equipment, process, ... equipment and assist in completing process deviation investigations/unplanned events. Author , review, and approve cGMP documentation - manufacturing process and… more
- Crusoe (San Francisco, CA)
- …a weekly one-pager to senior leadership team. Codify how Crusoe builds - author playbooks, RACI/RAPID matrices, RCCA loops, and turnover packages so new campuses ... execute the same winning formula. Budget + change-order sheriff - partner with Finance to catch scope creep, value-engineer solutions, and keep variance < 5 %. Org-builder - diagnose talent gaps, architect the org chart, hire and coach high-leverage operators… more
