- Catalent Pharma Solutions (Harmans, MD)
- …passion are essential to our mission: to help people live better, healthier lives. The ** Batch Record Reviewer I** is responsible for providing support to ... documentation practices (GDP), including but not limited to: executed batch records , master batch ...labels, SMPs, and product specific documents. + Independently executes batch record review for completeness,… more
- Catalent Pharma Solutions (Harmans, MD)
- …billions of doses of life-enhancing and life-saving treatments for patients annually. The ** Batch Record Reviewer I** is responsible for providing support ... documentation practices (GDP), including but not limited to executed batch records , master batch ...labels, SMPs, and product specific documents. + Independently executes batch record review for completeness,… more
- Catalent Pharma Solutions (Harmans, MD)
- …as routine production tasks. + Proficient knowledge of documentation including comprehension, review & establishing Batch Production Records , SOP's, ... manufacturing and support area of manufacturing using SOP's and batch records . Operating production equipment for upstream...Ensure batches adhere to established Quality standards. + GMP batch review and close-out with Quality Assurance… more
- Catalent Pharma Solutions (Harmans, MD)
- …of master/working cell banks, bulk drug substance and/or final drug product; conducts review of master batch records during Technical Transfer for ... include tracking and reviewing technology transfer documents, specifications, master batch records , change requests, deviations and failure investigations… more
- Insight Global (Rockville, MD)
- …cell & gene therapy -Minimum 5 years of experience performing QA responsibilities including batch record review , batch disposition, material release, and ... -Support in the execution and implementation of CAPAs. -Support in technical writing for batch records , SOPs, and other documents as needed. -Support in material… more
- Koniag Government Services (Baltimore, MD)
- …Cyberfusion, Managed File Transfer, connect: Direct) for failed or hung files. + Review batch job documentation for outdated information routinely and when ... & Duties may include, but are not limited to:** + Monitor batch production scheduling environments via multi-distributed platforms. + Process batch … more
- Catalent Pharma Solutions (Harmans, MD)
- …solutions; generates or revises GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMP's; compile deviations as required ... frame * Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good… more
- ManpowerGroup (Severn, MD)
- …Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record . + Documents/ Records cGMP data and information ... equipment + Stocking production and cleaning supplies + May author/ review /improve SOPs, batch records , protocols and technical reports + Actively… more
- ManpowerGroup (Severn, MD)
- …Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record . * Documents/ Records cGMP data and information ... equipment * Stocking production and cleaning supplies * May author/ review /improve SOPs, batch records , protocols and technical reports * Actively… more
- ManpowerGroup (Severn, MD)
- …Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record . * Documents/ Records cGMP data and information ... equipment * Stocking production and cleaning supplies * May author/ review /improve SOPs, batch records , protocols and technical reports * Actively… more
- Catalent Pharma Solutions (Harmans, MD)
- …The **Specialist III, MTO** will provide support to Manufacturing Associates to meet batch record review /disposition schedule to adhere to lot release ... quality reports and revising GMP documents such as SOPs and Manufacturing batch records . **This is a full-time on-site position,** **M-F 8am-5pm** **Catalent is… more
- Catalent Pharma Solutions (Harmans, MD)
- …implementation. Manage the OTL for analytical method implementation and support SMPs and Batch records implementation review . Catalent, Inc. is a leading ... stability studies. + Review and approve client sampling plans. + Review and approve batch records . Ensure sample testing schedule is accurate. + Develop… more
- Catalent Pharma Solutions (Harmans, MD)
- …Technician I** will be expected to support the execution of GMP manufacturing batch records and ensures necessary supply levels in the manufacturing areas. ... patient, consumer, and Catalent employee.** **The Role** + Execution of manufacturing batch records , SMP's, work instructions, and/or SOPs, with minimal… more
- Catalent Pharma Solutions (Harmans, MD)
- …to assist in technical knowledge transfer. + Assists manufacturing associates to meet batch record review /disposition schedule to adhere to lot release ... + Provide impact and risk assessments for Change Control Review Board (CCRB) records as the change...and revising GMP documents such as SOPs and Manufacturing batch records . + Participates and represents manufacturing… more
- Actalent (Baltimore, MD)
- …next production process. + Enter all batch data into the electronic batch records system. + Generate appropriate paperwork as needed per customer ... Identify and communicate product issues to other departments as needed. + Review batch slips for completeness and accuracy. + Create, maintain, and update… more
- Catalent Pharma Solutions (Harmans, MD)
- …training activities, managing individual training plan. + Assists manufacturing associates to meet batch record review /disposition schedule to adhere to lot ... and revising GMP documents such as SOPs and Manufacturing batch records . + Participates and represents fill/finish...expanding team. + Defined career path and annual performance review & feedback process. + Cross-functional exposure to other… more
- Catalent Pharma Solutions (Harmans, MD)
- …to assist in technical knowledge transfer. + Assists manufacturing associates to meet batch record review /disposition schedule to adhere to lot release ... quality reports and revising GMP documents such as SOPs and Manufacturing batch records . + Participates and represents manufacturing in cross-functional efforts… more
- Catalent Pharma Solutions (Harmans, MD)
- …well as routine production tasks + Excellent documentation skills including comprehension, review & establishing Batch Production Records , SOP's, deviation ... the safety of every patient, consumer, and Catalent employee.** **The Role** + Completes Batch Production Records under cGMP, and documents in detail through the… more
- Catalent Pharma Solutions (Harmans, MD)
- …biopharmaceutical manufacturing, highly preferred. + Excellent documentation skills including comprehension, review & establishing Batch Production Records , ... current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs), and Batch Production Records (BPRs) to manufacture sterile drug product… more
- System One (Harmans, MD)
- …meters. + Support the execution of GMP manufacturing + Execution of manufacturing batch records , work instructions, and/or SOPs + Documentation of all ... + Review daily GMP documentation for accuracy and completeness (Logbooks, Batch records ) Education: + High school diploma or GED required Requirements:… more