- Aequor (Athens, GA)
- …ongoing activities. Understanding of pharmaceutical and biological development processes and documentation is strongly preferred , due to the technical nature ... instructions. Understanding of typical pharmaceutical and/or biological development processes and documentation is strongly preferred . Must be able to create… more
- Repligen (Hopkinton, IA)
- …in a fast-paced environmentKnowledge of SAP is helpfulUnderstanding of Good Documentation Practices preferred .What Repligen OffersRepligen offers you a ... role is responsible for assisting the document control department in processing documentation requests. They will work closely with cross-functional teams and within… more
- Merck & Co. (South San Francisco, CA)
- …and communication skills. -Ability to produce clear, concise, and accurate documentation . Preferred Experience and Skills: -Knowledge of Chemistry, Molecular ... Biology, Biochemistry. -The ability to influence scientists to adapt to positive change. -Experience with regulatory submissions and understanding of the review process. -Familiarity with cloud-based data platforms and technologies (eg, AWS, Azure, Google… more
- Repligen (Hopkinton, IA)
- …project teams.Focus and attention to detail is critical.Understanding of Good Documentation Practices preferred .What Repligen OffersRepligen offers you a ... Two-year technical degree or equivalent from an accredited technical institution is preferred . Machine shop experience in the quality discipline or a related field… 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
- 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
- Aequor (Thousand Oaks, CA)
- …required, as full training will be provided. Strong attention to detail, good documentation practices (GDocP), and comfort with lab notebooks and SI pages are ... is not limited to, the maintenance of training records, laboratory documentation , written procedures, building monitoring systems and laboratory logbooks. … more
- Merck & Co. (Rahway, NJ)
- …silico models and AI/ML approaches for drug discovery.Create and maintain documentation including SDLC deliverables (GxP and non-GxP), guidelines, SOPs, training ... inspections by collaborating with stakeholders and Quality units to provide documentation and respond to inquiries.Actively drive product adoption by analyzing… 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)
- …activities for System Development Life CyclePrepare, review, and approve documentation such as master inventory lists, qualification documentation , ... working within a GMP environment.-Understanding of GMP policies and procedures. Preferred Experience and Skills-While not required, experience in one or… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of authorship agreements, financial disclosures and author approvals- Ensure documentation of compliance with authorship and publication guidelines as stipulated ... in Health Sciences required- Other advanced degree preferably in Health Sciences preferred or- PharmD or PhD in Health Sciences preferredExperience Qualifications- 7… 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
- Aequor (Thousand Oaks, CA)
- …degree with six months of experience is also acceptable. A bachelor's degree is preferred but not required. Previous experience with GMP is a plus but not mandatory, ... of raw materials and components and for performing Quality review of documentation for assigned functions (eg equipment and maintenance records). Duties will include… 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
- Merck & Co. (Durham, NC)
- …and support functions necessary for production. Provides and/or authors all documentation and clerical functions necessary to allow proper accountability and ... on, 2 days off, 3 days on) which includes every other weekend. Preferred Experience and Skills: Experience training others through hands-on training Experience with… more
- Merck & Co. (North Wales, PA)
- …of programming deliverablesProduce SAS transport files and associated documentation for regulatory submissionsEducation and Minimum Requirement:BA/BS in Computer ... safety) and pharmacokinetic data (raw concentration data, derived PK parameters). Preferred Skills and Experience: Familiarity with pharmacokinetics modeling and… more
- Merck & Co. (North Wales, PA)
- …regulatory applications and ensure quality and compliance across all documentation .Interact independently with regulatory agencies (FDA, EMA, etc.), including ... (eg, FDA, EMA).Demonstrated success in managing regulatory filings across global regions. Preferred Experience and Skills Therapeutic area expertise in Oncology or… 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
