- Merck & Co. (Durham, NC)
- …comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.- - The Quality Senior Specialist provides expertise in the coordination of ... supporting the vaccine expansion facility. - Primary Responsibilities: The Quality Senior Specialist will be responsible for comprehensive management of… more
- J&J Family of Companies (Raritan, NJ)
- Batch Release Senior Specialist - 2406220990W **Description** Johnson & Johnson Innovative Medicine is recruiting for a ** Batch Release Senior ... product specifications. Ensure all required testing and documentation is provided and meets release requirements. * Perform batch release in accordance with… more
- WuXi AppTec (Philadelphia, PA)
- …* Interacts with QA Manufacturing to communicate project requirements, and timeline to perform batch release * Writes, reviews and revises SOPs as required * ... insurance + and much more The **Quality Assurance Manufacturing Specialist III** is a senior role to...and approves non-conformances, deviations, and CAPAs that are not batch -specific. Author and revise departmental SOPs to stay current… more
- Catalent Pharma Solutions (Hanover, MD)
- …(EHS), quality systems and cGMP requirements + Understand risks and delays to batch release and communicate appropriately + Identify and participate in internal ... **Sr. Specialist , QA - Batch Disposition** **Summary:**...and SOPs + Compile and report performance metrics for Batch Review and Release + Contributes to… more
- Verista (Boston, MA)
- …+ Experience providing QA support and oversight of GMP manufacturing operation including batch release + Experience with ATMP drug product development and ... of assembly, packaging and label operations + Responsible for batch disposition activities. Review batch data, including...batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to… more
- Merck (Durham, NC)
- **Job Description** ** Senior Specialist , Quality Systems and Compliance (P3)** Our company is expanding its global recombinant vaccine production network by ... comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps. The Quality Senior Specialist provides expertise in the coordination of… more
- Catalent Pharma Solutions (Harmans, MD)
- …Performs QA on the Floor activities supporting client projects, including room release , observing critical processes, reviewing batch documentation in real time, ... **Sr. Specialist , QA OTF** **Position Summary** Catalent is a...(AQL) visual inspection of drug product; reviews and approves batch documents for media and buffer prep solutions; generates… more
- Endo International (Horsham, PA)
- …QA team members. Batch Record/Reports Review + Supports the QA batch release functions for cGMP commercial, clinical, and development manufacturing and ... review of annual product review and updates for regulatory filing(s), batch release metrics, and department reporting as applicable. + Releases consumables and… more
- Bristol Myers Squibb (Devens, MA)
- …Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs. + Perform walkthroughs of GMP ... experienced staff. + Support the Quality approval of Master Batch Records or Syncade Recipes. + Supports the Quality...closure of no impact manufacturing deviations. + May support release of incoming or manufactured products. + Routine QA… more
- University of Pennsylvania (Philadelphia, PA)
- … (Regulatory) CVPF(Center for Cellular Immunotherapy) Job Profile Title Research Coordinator Senior Job Description Summary The Quality Assurance Specialist will ... clinical trials in immunotherapies. Main duties include: + Review of manufacturing batch records and product release documentation under tight deadlines with… more
- Amgen (Holly Springs, NC)
- …Amgen North Carolina commercial product release . Scope includes in-process, release , stability, and characterization testing. The Senior Manager QC Chemistry ... most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional… more
- Waystar (Atlanta, GA)
- …team is also responsible for building and managing the core system logic to batch payment data and integrate with the banking system for funding and accounting. The ... we are looking for an outstanding, brilliant, and driven Specialist Application Engineer to join our growing team. While...requirements + Communicates the development progress daily to the senior -level team members + Attends to any work items… more
- Gilead Sciences, Inc. (Foster City, CA)
- …progress, change orders, or other delaying conditions. + Establishes sequence and lead-time of each batch to meet CMO release dates. + Updates ERP system data to ... Join Gilead and help create possible, together. **Job Description** Reporting to the Senior Manager, this role will be responsible for ensuring timely execution of… more
- Healgen Scientific Limited (Kinderhook, NY)
- …of incoming raw materials, in-process, and finished products. Assist manufacturing with batch release and other relevant documentation. Assist with post-market ... Quality Assurance Specialist Quality Assurance | Kinderhook , NY Apply...required. Assist in other duties as assigned by the Senior QA Manager. Qualifications Have at least 4-5 years… more
- Navy Exchange Services (NEX) (Virginia Beach, VA)
- …support services. Incumbent seeks guidance from the DBA Web Services Supervisor and Senior DBA Web Administrators to gain knowledge and proficiency in database and ... Incumbent may progress non-competitively to Job Code Number 8535, Computer Specialist (Database/Web Services Admin Level 3) upon completion of training, obtaining… more
- Integra LifeSciences (Cordova, TN)
- …Document and Change Control + Training + Internal and External Auditing + Product Release and Batch Record reviews + Quality record reviews, inspections and ... readiness and compliance and meets established criteria for testing and product release schedules. + Management of Training Program and Records Management. + Ensures… more
