- Cipla (Hauppauge, NY)
- …materials to maintain product quality and compliance. Ensure proper storage, labeling , and inventory management of printed packaging materials (labels, cartons, ... regulatory guidelines (eg, FDA, EMA) and industry standards, including proper labeling , dosage information, and claim. Maintain and organize a comprehensive archive… more
- Cipla (Central Islip, NY)
- …storage and check dispensed materials/final mix blend/compressed tablets and labeling as per BMR. Wear appropriate personal protective equipment (PPE) ... as stated in the SOP/BMR before initiating the process. Able to operate applicable equipment independently as per area of operation. Ensure adherence to quality standards during all stages of the manufacturing process. Complete manufacturing documents on time,… more
- Cipla (Central Islip, NY)
- …storage and check dispensed materials/final mix blend/compressed tablets and labeling as per BMR. Wear appropriate personal protective equipment (PPE) ... as stated in the SOP/BMR before initiating the process. Able to operate applicable equipment independently as per area of operation. Ensure adherence to quality standards during all stages of the manufacturing process. Complete manufacturing documents on time,… more
- Cipla (Central Islip, NY)
- …specifications and regulations established for packaging process. Operate automatic filling, labeling , and sealing equipment. Perform cleaning of the packaging room ... and equipment. cGMP/Documentation: Perform all functions according to current Good Manufacturing Practices (cGMP) and company Standard Operating Procedures (SOP). Accurately and legibly document in applicable Log Books Determine when to stop a line related to… more
- Cipla (Hauppauge, NY)
- …as required for sampling, inspection, status label changes, and ensure proper labeling . Move materials from Quarantine to Released or Rejected areas as directed ... by Warehouse Management and ensure storage locations are updated on daily basis by working with Warehouse Coordinator. Perform dispensing activities for Packaging and Raw materials and ensure cGMP and GDP practices by closely working with QA department. Picks… more
- Formation Bio (New York, NY)
- …ensuring that all GMP-regulated activities, including manufacturing, testing, packaging, labeling , storage, and distribution of Formation Bio's portfolio are ... executed in compliance with regulatory requirements, industry standards, and company procedures. This role supports CMC development activities, audits CDMOs, conducts batch release, and performs investigations. The ideal candidate is a hands-on quality… more
- Cipla (Central Islip, NY)
- …with specifications and regulationsestablishedfor packaging process. Operate automatic filling, labeling , and sealing equipment. Perform cleaning of the packaging ... room and equipment. cGMP/Documentation: Performall functions according to current Good Manufacturing Practices (cGMP) and company Standard Operating Procedures (SOP). Accurately and legibly document inapplicableLog Books Determinewhen to stop a line related to… more
- Formation Bio (New York, NY)
- …of use patents, lifecycle management strategies, process-related discoveries and labeling -related IP issues Oversee trademark, trade secret, and data exclusivity ... strategies Advise on IP issues to multidisciplinary scientific and engineering teams, including ML/data scientists and with respect to our AI product features Comfortable working cross functionally, including partnering with clinical and CMC teams to identify… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …the organization to drive and align the development and maintenance of global labeling (eg CCDS, regional product labels, and patient labeling ) for assigned ... compounds. Makes recommendations and provides labeling advice and feedback for labeling content, processes, and timelines to ensure compliance with labeling … more
- Parexel (Albany, NY)
- …Parexel is seeking an experienced and highly motivated **Global Regulatory Labeling Lead** to provide strategic leadership and operational oversight for complex ... global labeling initiatives. This role is integral to the development,...integral to the development, governance, and maintenance of regulatory labeling content that supports the safe and effective use… more
