- Repligen (Hopkinton, IA)
- …Quality Management System. This role is responsible for assisting the document control department in processing documentation requests. They will work closely ... subject matter experts, area managers and senior level Document Control and QA-personnel to properly convert documentation ...Document Control and QA-personnel to properly convert documentation into the final written form and ensure the… 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,...cGMPs, and other applicable regulatory requirements. Adhere to good documentation practices. Complete all required training before starting any… more
- Aequor (West Greenwich, RI)
- …routine laboratory procedures. 3. Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks. 4. Operate and ... maintain specialized laboratory equipment and instrumentation. 5. Participate in laboratory investigations and audits as necessary. 6. Perform general laboratory housekeeping activities. 7. Maintain training compliance and proficiency. 8. At all times, comply… more
- Aequor (Cincinnati, OH)
- Quality Control Analyst I Does the position allow for the worker to be virtual/remote? No Temp to Perm: Temp to perm based on openings and performance Shift ... of USP, cGMP, and FDA regulations Create and maintain lab record documentation (notebooks and computer based) according to GMPs Demonstrate the philosophy of… more
- Aequor (Swiftwater, MN)
- …position supports the execution of routine testing in the Quality Control Analytical Chemistry laboratory, including chemistry assays associated with Incoming ... pre and post-run setup and maintenance. Complete required paperwork and documentation as required. Troubleshoot sample discrepancies. Perform peer proofing on… more
- Repligen (Waltham, MA)
- …and external financial reporting, including SEC filings support (10-Q, 10-K)Maintain documentation to support SOX internal control complianceParticipate in audit ... close processes and ensures compliance with US GAAP and internal control requirements (SOX). This position supports general ledger accounting, account… more
- Merck & Co. (Rahway, NJ)
- …Operations - API, is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture, ... clinical supply programs. This person will also independently review and approve documentation accompanying the disposition of API materials to ensure conformance to… more
- Merck & Co. (Rahway, NJ)
- …will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing ... in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization. Risk… more
- Tris Pharma (Monmouth Junction, NJ)
- …in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/Regulatory Affairs, including reviews/approvals of Change Control ... well as test methods and proceduresPrepares CCRs, according to change control processCoordinates, advances and monitors progress for all required documentations and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …derive insights Comfort operating in a fast-paced, environment, with a quality control focus and a documentation orientation Creative problem-solving with ... ability to solve complex unstructured problems; see opportunities through Experience analyzing pharmaceutical data, specifically Xponent, Xponent PlanTrak, data is required. Experience with data visualization (ie Tableau) tools preferred Innate intellectual… more
- Merck & Co. (Durham, NC)
- …production equipment in a clean room environment. Responsible for written documentation of activities.- Actively supports, participates and embraces an empowered ... between Mechanical Service Engineer (MSE) and Operations.Review work order documentation .Accountable for work order proper handling.Train other mechanics on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experience required. Comfort operating in a fast-paced, environment, with a quality control focus and a documentation orientation Innate intellectual curiosity, ... demonstrated desire to take initiative, and ability to think creatively to solve complex problems Ability to effectively integrate and communicate insights to Senior Management teams, synthesize complex information, making it relevant, understandable and… more
- Merck & Co. (Durham, NC)
- …production equipment in a clean room environment. Responsible for written documentation of activities.- Actively supports, participates and embraces an empowered ... testing, as requiredFollows instructions for completion of job tasks.Completes written documentation of work performed.Efficient and safe maintenance and repair of… more
- AUROBINDO (Durham, NC)
- …team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, ... The Receiving Supervisor must ensure that all the appropriate documentation has been provided to APUSA and submit the...position is also required to work closely with Quality Control to make sure that the process flows smoothly… more
- Merck & Co. (Rahway, NJ)
- …industry.Required Experience and Skills: Strong background in integrated analytical control strategy development and execution. Demonstrated ability to lead a ... knowledge and experience with regulatory guidance and industrial standards of control strategy for residual HCPs and other process related impurities in… more
- Merck & Co. (Rahway, NJ)
- …such as User Guidance and Standard Operating Procedures (SOP) and change control management is desirable.Good understanding of SDLC Documentation requirements ... IT Business Partners including activities relating to Requirements Gathering, Documentation , Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee… more
- Twist BioScience (South San Francisco, CA)
- …is responsible for ensuring the efficient and compliant management of regulatory documentation , with a primary focus on Safety Data Sheets (SDS), product labeling, ... crucial in supporting global product compliance, ensuring that all documentation accurately reflects regulatory requirements and product specifications.What You'll… more
- Merck & Co. (Rahway, NJ)
- …substance processes. Your insights will be crucial for establishing an integrated control strategy suitable for commercialization and licensure for the products in ... foster collaboration and innovation.Document Excellence: Author regulatory and technical documentation , ensuring all processes align with our company's expectations.Mentor… more
- Eisai, Inc (Exton, PA)
- …pilot plant, including scheduling of staff, preparation and close-out of documentation , manufacture of DS/ADI materials, and suite change-over ensuring compliance to ... validation protocols and reports, and SOPs, along with providing supporting documentation . They formulate the overall strategy for Upstream and Downstream Operations… more
- Merck & Co. (Durham, NC)
- …member of the Site Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.This Individual ... will be-responsible for problem resolution, implementation of process control , data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety,… more
