- 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
- Merck & Co. (Rahway, NJ)
- …Operations with Labeling Process and/or Digital Enablement experience strongly preferred , and experience with IT System/Business System Management.Education Min. ... experience in System Development/Management within Manufacturing or Research areas preferred .Start date: -As soon as possible.Job Description: Seeking a full-time… 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
- 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
- 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
- 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. (Upper Gwynedd, PA)
- …of global regulatory CMC requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.Lead the ... transition to the Post-Approval Pharm CMC team.Manage execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to… 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines.Authoring and reviewing internal technical reports, ... matrix management and peer to peer coaching.Accurately and efficiently documentation of experiments.Strong ability to deliver complex objectives under aggressive… more
- Aequor (Thousand Oaks, CA)
- …in a relevant scientific field (eg, biology, chemistry, biochemistry) is preferred , direct industry experience is more important. Candidates should be familiar ... operational goals and will work in a team matrix environment. Preferred Qualifications: Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science… more
- Twist BioScience (South San Francisco, CA)
- …validation (CSV) activities, including IQ, OQ, PQ protocols and documentation , specifically tailored for custom software.Electronic Batch Record (EBR) Management: ... Electrical Engineering, or a related technical field. Master's degree preferred .12+ years of progressive experience in software development and technical… 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
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