- Repligen (Hopkinton, IA)
- OverviewWe are seeking a Document Control/ QA Associate I to join our growing Quality Department team in Hopkinton, MA for 1st shift operations (M-F) from 8 ... Associate I will report directly to the QA /QC Director .This position is responsible to actively...responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for assisting… more
- Eisai, Inc (Exton, PA)
- …, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established and ... difference. If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …to the best of my knowledge. **Job Description** About the role: As the Head of Quality Assurance you will lead quality oversight to ensure that all products ... standards across global markets. You will oversee critical quality systems including batch record review, product... quality policies, and government regulations + Support Quality Assurance Programs to improve safety, customer… more
- Lilly (Concord, NC)
- … QA Materials Disposition Sr. Manager will report to the Associate Director Quality (Materials). The QA Materials Disposition Sr. Manager manages, ... the site e-release process + Manage a team of QA incoming batch disposition associates + Responsible...Participates in/supports regulatory inspections, as needed. + Communicates with QA Associate Director Materials and… more
- Lilly (Durham, NC)
- …for ensuring team is trained and training remains in compliance. + Communicates with Associate Director and Quality Representatives on quality issues. ... -Incoming Inspection is responsible for providing leadership to the Quality - Incoming Inspection team. The QA ...SmartLab, etc). + When sampling a portion of the batch , ensure proper sampling plan is followed. + Working… more
- Lilly (Indianapolis, IN)
- …in Indianapolis at LTCN and at partner sites across the globe. **Responsibilities:** As the QA Associate Director , you will lead a team that provides ... the world. **Organization Overview:** Product Research and Development (PRD) quality assurance ( QA ) supports the...oversight and executes batch release processes for all API used for clinical… more
- Bristol Myers Squibb (Summit, NJ)
- …better place than here at BMS with our Cell Therapy team. The purpose of the Associate Director , Value Stream CAR T Manufacturing role is to manage and provide ... (WIs). + Responsible to own, review, author, or approve SOP, WI, master batch records. + Responsible for setting strategic direction for the WCT while maintaining… more
- Lilly (Pleasant Prairie, WI)
- …who are determined to make life better for people around the world. The Associate Director , Operations - Filling for parenteral operations is responsible for the ... of the parenteral operations areas. After starting up, the Associate Director will be responsible for leading...contact for other areas such as Production Planning, HR, Quality Assurance , Engineering and Environmental/Safety issues. +… more
- Lilly (Durham, NC)
- …are determined to make life better for people around the world. The Operations Associate Director of Device Assembly is responsible for the staffing, training, ... as a primary contact for other areas such as Production Planning, HR, Quality Assurance , Engineering and Environmental/Safety issues. + This role has direct… more
- Fujifilm (College Station, TX)
- **Position Overview** The Senior Director Quality Operations is responsible for QA oversight of CGMP manufacturing operations and areas at one of our ... manufacturing facilities at FDBT. Lead the Quality Operations organization to create a strong ...working relationships with internal and external stakeholders. Direct all QA on-the-floor (QAOTF), batch record review (BRR),… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- **Job Summary** **** The Associate Director , MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing ... oversight of downstream manufacturing operations at CDMOs, including review of batch records, deviation investigations, and change controls. + Lead or significantly… more
- Otsuka America Pharmaceutical Inc. (Carson City, NV)
- …skilled and experienced professional to join our organization as the Assoc. Director of Manufacturing Science and Technology (MSAT) for Upstream processes. This ... oversight of upstream manufacturing operations at CDMOs, including review of batch records, deviation investigations, and change controls. + Lead or significantly… more
- Charles River Laboratories (Rockville, MD)
- …passionate about. **Job Summary** This position reports to the Site Head of Quality , and the person filling this role is responsible for partnering with functional ... stakeholders at the site level to ensure Quality performance and Compliance is designed into, and maintained, across all strategic initiatives, Operations,… more
- Mount Sinai Health System (New York, NY)
- …new seeds, testing crawls, scheduling repeating crawls, creating metadata, and performing quality assurance . + Maintain relationships with outside vendors to ... one scripting language (ideally Python), sufficient to carry out batch data clean-up and digital processing workflows, or willingness...the contents of the Mount Sinai Archives. Coordinate with Director of Archives and Associate Archivist for… more
- Unither Pharmaceuticals (Rochester, NY)
- …and Capsules. It has more than 280 employees. Your role Reporting to the Quality Director , JOB SUMMARY: This is a team-oriented position with the individual ... other departments including, but not limited to: Information Technology, Operations, Engineering, Quality Assurance , and Product Development to provide a high… more
- Lilly (Greenville, NC)
- …for the External Manufacturer. + Inform TS/MS (Technical Service/Manufacturing Science) Associate Director about project status and issues. **Department ... + Define and own the process control strategy, including key parameters and quality attributes. + Understand product history and potential failure modes. + Educate… more
