- Exela Pharma Sciences, LLC (Lenoir, NC)
- …department leaders. Review and participate in manufacturing documentation such as Protocols, Batch Records and Risk Assessments. Review and participate in ... protocols, and performance qualifications.Some part of the job requires working late or night shifts or a Pitman schedule as company needs evolve. The Pitman… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Batch Record Reviewer ** **Summary:**...documentation practices (GDP), including but not limited to: executed batch records , master batch ... AAV and other viral vector-based therapies and vaccines._ The ** Batch Record Reviewer ** is responsible...validation protocols and reports and SOPs + Independently executes record review for completeness, accuracy and cGMP… more
- Kelly Services (Lodi, CA)
- … records and documents, for completeness and compliance with QSR and ISO requirements. + Review batch record to support release of raw materials, work in ... Week 2: Thursday/Friday/Saturday + Team C: Sunday/Monday/Tuesday/Every other Saturday, Night : 6:00 PM - 6:00 AM + Week 1:...signing in relevant sections of documents. + Reviewing the batch records online, if necessary. + … more
- Amgen (Holly Springs, NC)
- …in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBR]) + Complete washroom activities: cleaning ... most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional… more
- Niagara Bottling LLC (Temple, TX)
- …completion of assigned work. + Review documents such as Protocols, Batch Records , Change Controls, Deviations, CAPAs, Risk Assessments, etc. + Evaluates ... benefits packages for our Team Members. Aseptic Operations Supervisor ( Night Shift) The Aseptic Operations Supervisor is responsible for...employees on a daily basis + Ensure that all Batch Production Records are correctly filled out… more
- Catalent Pharma Solutions (Harmans, MD)
- …well as routine production tasks + Excellent documentation skills including comprehension, review & establishing Batch Production Records , SOP's, deviation ... safety of every patient, consumer, and Catalent employee.** **The Role:** + Completes Batch Production Records under cGMP, and documents in detail through the… more
- Novo Nordisk (Clayton, NC)
- …+ Perform routine cleaning and good housekeeping as needed for assigned areas + Review electronic batch records real-time to ensure compliance to Standard ... storage & process waste systems preferred + Ability to work with electronic batch records , automated process equipment, and/or DeltaV or Syncade preferred +… more
- Lilly (Concord, NC)
- …site procedures. + Review and approve GMP documentation such as electronic batch records , logbooks, etc. + Support creation of Standard Operating Procedures ... inspection + Previous experience with Manufacturing Execution Systems (MES) or electronic batch records + Previous technical writing experience + Technical… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …reworks, and Material reconciliation that goes along with the batch . Primary Responsibilities: + Production: + Operate high-speed manufacturing equipment, ... all job-related SOPs + Quality: + Ensure that all batch paperwork is completed in an accurate, thorough, and...and regulatory agency regulations + Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …inspections, reworks and Material reconciliation that goes along with the batch . Primary Responsibilities: + Production: + Operate high speed manufacturing ... job related SOPs + Quality: + Ensure that all batch paperwork is completed in an accurate, thorough, and...and regulatory agency regulations + Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary… more
- ThermoFisher Scientific (St. Louis, MO)
- …manufacturing processes. + Review and provide technical feedback on manufacturing batch records , validation protocols, and process flow diagrams. + Solve ... contributions to the world. How will you make an impact? As a Night 's Supervisor in Manufacturing Sciences at Thermo Fisher Scientific Inc., you will have… more
- Lilly (Concord, NC)
- …site procedures. + Review and approve GMP documentation such as electronic batch records , logbooks, etc. + Troubleshoot and provide support to resolve issues ... supporting all HSE Corporate, Project, and Site Goals + Ability to work a 12-hour night shifts onsite on a rotating 2-2-3 schedule (not eligible for remote work) +… more
- ThermoFisher Scientific (Manati, PR)
- …present. + Verify accurate product lot numbers and components used per the manufacturing batch record and Fourth Shift System. + Perform the required document ... **Environmental Conditions** Office **Job Description** **Discover Impactful Work:** + Review manufactured lot documentation to ensure good documentation practices… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …maintaining compliance with all job-related SOPs + Quality: + Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner + Perform ... all company and regulatory agency regulations + Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture… more
- Amgen (New Albany, OH)
- …providing QA guidance and support to AOH production, and you will be performing Quality Batch Record Review of all commercial batches labelled and packed at ... quality matters, while driving the site Quality culture. + Review and approve batch production record...product checks during (commercial) production runs + Compile and review batch records for lots… more
- Bristol Myers Squibb (Devens, MA)
- …with applicable procedures and batch records , providing real time review of manufacturing batch record documentation and logbooks, and working ... the Devens CTF. **This position works on a rotating night shift from 6pm - 6am** **REQUIRED COMPETENCIES: Knowledge,...manufacturing compliance with applicable procedures and batch records . + Perform real time review of… more
- Takeda Pharmaceuticals (Brooklyn Park, MN)
- …parameters in batch record and control systems. + Accomplish batch records and validation protocols under guidance/direction of others. + Review ... and/or equipment activities while following standard operating procedures. Main documentation includes batch records , work orders, and equipment logbooks. + With… more
- ThermoFisher Scientific (High Point, NC)
- …Make an Impact?** The In-Process Quality Assurance (IPQA) Technician II will be responsible for review of batch production records in real time to ensure ... **A Day in the Life:** + Logs and reviews Batch Production Records + Performs finished product...finished product quality assurance sampling/inspection and submits documentation to Batch Release for review . + Pulls retain… more
- Catalent Pharma Solutions (Chelsea, MA)
- …Oversight (with limited supervision) of production activities, including area clearance, issuance and review of batch records , and making decisions on ... **Quality Assurance Specialist II - Night ** **Position Summary:** Catalent is a global, high-growth,... and approval of SOPs, Protocols, Reports, and Master Batch Records for continuous improvement; + Initiation… more
- ThermoFisher Scientific (St. Louis, MO)
- …filtration or centrifugation. **A day in the Life:** + Execution of manufacturing batch records , work instructions and/or SOPs, with focus on proactive 'right ... the first time' executions. Assist with batch record reconciliation + Assist in all...meet cGMP requirements. Complete document reviews and revisions. Daily record review , tasks, and databases. Participate/Lead in… more
