- Aequor (Athens, GA)
- …ongoing activities. Understanding of pharmaceutical and biological development processes and documentation is strongly preferred, due to the technical nature of the ... instructions. Understanding of typical pharmaceutical and/or biological development processes and documentation is strongly preferred. Must be able to create clear … more
- Aequor (Tampa, FL)
- …tax compliance and reporting for the region, encompassing transfer pricing documentation , intercompany transaction analysis, and tax provision support. This position ... e-invoicing and tax compliance processes. Responsibilities: Transfer Pricing and Tax Documentation Prepare and maintain comprehensive documentation for transfer… more
- Repligen (Hopkinton, IA)
- …role is responsible for assisting the document control department in processing documentation requests. They will work closely with cross-functional teams and within ... also serving as a resource for the review of quality documentation received from interdepartmental sources.ResponsibilitiesWorks with subject matter experts, area… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant with relevant regulations. This ... for coordinating the authoring, review and approval of new or updated procedural documentation . In addition, this role will work closely with process owners, subject… 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
- Merck & Co. (Rahway, NJ)
- …Business Partners including activities relating to Requirements Gathering, Documentation , Testing, Implementation, Deployment and Hypercare phases.Facilitate and ... for workflow management is an asset.Strong aptitude for authoring Technical Guidance documentation such as User Guidance and Standard Operating Procedures (SOP) and… more
- Merck & Co. (Rahway, NJ)
- …activities for System Development Life CyclePrepare, review, and approve documentation such as master inventory lists, qualification documentation , ... calibration documentation , computer system inventories Support internal and external quality audits and maintain laboratory state of permanent inspection readiness Author or contribute to Standard Operating Procedures (SOP) draftingOriginate and own… more
- Aequor (Thousand Oaks, CA)
- …EHSS, cGMPs, and other applicable regulatory requirements. Adhere to good documentation practices. Complete all required training before starting any tasks. Work ... lab, checking to ensure removal of expired media performed, archiving documentation , preliminary plate readings etc. Support Microbiology lab with analytical… more
- Merck & Co. (Rahway, NJ)
- …of the facility.Ensure facility readiness with respect to cleaning (including documentation and execution), dummy run and batch execution, building housekeeping, and ... executing batch production work. Additional responsibilities include coordination, planning, documentation , and other facility improvement activities. Position Qualifications: Education… more
- Aequor (Athens, GA)
- …including cleanliness of assigned facilities and the completion of all documentation activities to comply with FDA/EU and Good [Laboratory, Clinical, Manufacturing] ... Completes operational log paperwork, daily log files, and work order documentation with appropriate detail and accurate information utilizing a combination of… 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
- 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
- Eisai, Inc (Nutley, NJ)
- …eTMF assist with set-up requests andAssists with filing and archiving project documentation in the eTMF within the defined timelinesPerforms eTMF internal reviews, ... detailed eTMF CRO quality check reviews with follow-up for missing documentation under the supervision of the COLProvides general enrollment figures to… more
- Aequor (Pearl River, LA)
- …preparation areas of the cGMP commercial manufacturing facility. Requires good documentation skills and attention to detail. Duties will include the operation, ... issues, troubleshoot, propose solutions, and keep management informed. Ensure good documentation practices (GDP) in execution and reviews of production records.… more
- Aequor (Thousand Oaks, CA)
- …of raw materials and components and for performing Quality review of documentation for assigned functions (eg equipment and maintenance records). Duties will include ... Excellent communication skills Time management Proficient computer skills (ie documentation systems, databases and spreadsheets). Bachelor's degree OR Associate's… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, utilities, and ... and maintenance activities within the siteReview and approve qualification/validation documentation (specifications, protocols, reports).Review and approve periodic review … more
- Merck & Co. (Rahway, NJ)
- …GMP and developmental use.- Author, review and approve GMP procedures and documentation , with an emphasis on Qualification and Validation plans around equipment, ... plans and annual reports around critical equipment and systems.- Maintain GMP documentation where applicable, such as GMP engineering drawings and equipment database… more
- Repligen (Hopkinton, IA)
- …inventory counts and report any inaccuracies on in a timely mannerComplete documentation according to Good Documentation Practices (GDP)Learn the Repligen ... Performance System and contribute to a culture of continuous improvementOther Duties:Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for… more
- AUROBINDO (Durham, NC)
- …activities for APUSA. The Receiving Supervisor must ensure that all the appropriate documentation has been provided to APUSA and submit the Pre-alert documents to ... Materials, Packaging Materials, etc.), ensuring accuracy of shipments and supporting documentation , receiving incoming materials and routing to appropriate area or… more
