...Analytical Technologies, IPC lifecycle, Data Analytics, Manufacturing Support, Process Validation and Process Solutions.
As a Temp Data Review Associate you will establish, organize and maintain effective process data co-ordination and data evaluation services.
A typical...
...investigations, etc
Participating in training of other new employees and prioritizes workloads on a daily basis
Performing peer review of data
Performing laboratory investigation reports
Performing microbial identification procedures
Maintaining laboratory supplies...
...procedures, training materials and EHS related procedures
Participating in process and system walk-downs and the completion of safety reviews with active follow up of action closure
Identifying and addressing site EHS issues and employee concerns
Performing EHS risk...
...processes
Documents clear and testable requirements which describe a technology to be implemented
Collaborates in the creation, review and approval of validation documents
Recommends business process and system changes to improve efficiency and business outcomes...
...allocation of resources
Building effective relationships with other departments and functions within the organization
Compiling, reviewing and approving documentation
Driving continuous improvement initiatives/programs
May support the site through regulatory audits...
...Essential Duties and Responsibilities include, but are not limited to, the following:
Responsible for all aspects of QA Team including review and approval of the following types of documents, relating to area functions: Master records / executed records / failure...
...with current GMP, the required regulatory standards, conforming to company policies and standard operating procedures (SOPs)
Peer reviewing data from other analysts for accuracy and completeness
Performing Bioassays in compliance with cGMP practices
Subculture mammalian...
...Reference Standards and Materials Management.
Manages the lifecycles of Reference Standards.
Gathers data and documents results.
Reviews reports to ensure compliance with standards; reports any quality anomalies.
Complies with all pertinent regulatory agency...
...and support for audit and inspection activities.
May serve as liaison between Regeneron and 3rd Party Logistics Warehouses.
May review and update method statements and safety Risk assessments’ as required
Continuously supports Warehouse & Logistics, with data extracts...
...continuous improvement opportunities (i.e. real time process monitoring)
Issuing knowledge base reports summarizing conclusion of data reviews and analysis.
To be considered for this opportunity you should have a MSc in statistics, mathematical sciences or related field....
...Assisting in troubleshooting activities associated with the manufacturing process
Supporting technology transfer activities as needed. Reviewing Manufacturing documentation associated with the transferred process
To be considered for this opportunity you should have a BS/BA...
...the management of Change Controls, Deviations, CAPAs
Provides Technical Writing assistance with the completion of System Periodic Reviews.
Supports the execution of System Audit Trail Reviews
Tracks and reports on IOPS IT Quality Metrics
Champions Data Integrity...
...include, but is not limited to, the following:
Independently leading non-conformance investigations to prevent reoccurrences
Reviewing Equipment Drawings, Schematics, Life Cycle Documents, and Automation programming
Reviewing SOPs, Work Instructions, Batch Sheets,...
...bi-weekly and monthly payrolls.
As a Temp Payroll Analyst, a typical day might include but are not limited to, the following:
Reviewing all administrative payroll data changes to records for processing
Reconciles each payroll, reviews all entries and forwards for approval...
...problems at the application server level
Participating or leading IT Applications systems security access and periodic audit trail reviews
Other duties as assigned
This role might be for you if you:
You have worked in a regulated laboratory setting
You enjoy...
...solving methodologies such as fishbone, 5 Whys to establish root cause of deviations
Working closely with Manufacturing Managers to review and evaluate quality event information
Assessing event for impact to SISPQ, conduct risk assessments and initiating appropriate...
...of the manufacturing processes
Key person for technical input into manufacturing records, batch sheets and procedures
Writing, reviewing, Standard Operating Procedures and other controlled documents as needed
Providing technical input to resolve process problems...
...CAPA's and Workflows
Coordinating cross functional teams during Change Control/CAPA events and align team on approach forward
Reviewing, editing, and revising controlled documents ( logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written...
...piping, and controls
Managing small-to-mid sized projects related to process equipment and manufacturing
Assisting in the design review, site acceptance and installation of equipment
Preparing piping and instrumentation diagrams and other related drawings...
...Collaborates with cross functional teams to resolve issues, complete investigations and maintain compliance.
Responsible for QA review and approval of the following types of documents:
- Failure investigations
- Corrective and preventative actions (CAPA)
- Standard...
...laboratory investigations, etc.
Participating in training of new employees and prioritizing workloads on a daily basis
Performing peer review of data
Performing laboratory investigation reports
Performing microbial identification procedures
Maintaining laboratory...
...Operations, processes and directing the activities of the QA Operations management team
Owning and continuously improving the batch review activities to support batch disposition of Regeneron Products
Overseeing Ireland Document Control (DC) operations and directing the...
...As a Process Engineer in the Technology Transfer department a typical day might include, but is not limited to, the following:
Review process data identify and report shifts or outliers
Discover opportunities to improve process reliability, repeatability, compliance...
...problems at the application server level
Participating or may lead IT Applications systems security access and periodic audit trail reviews
Other duties as assigned
This role may be for you if you have:
Experience with technical writing & process mapping
Good...
...Assisting in troubleshooting activities associated with the manufacturing process
Supporting technology transfer activities as needed
Reviewing and/or approving Manufacturing documentation associated with the transferred process
To be considered for this opportunity you...
...Supervising QC Analysts and Shift leads - distributing workload and monitoring progress
Supervising and performing product testing and reviewing test reports.
Ensuring QC Analysts receive accurate training
Experience with HPLC/UPLC and Empower
Attending...
...Analysts, distributing work load, and monitoring progress
Overseeing product testing to ensure efficient and compliant operations
Reviewing test reports
Ensuring QC Analysts receive proper training
Attending meetings to keep informed of manufacturing priorities...
...this role you will be responsible for the commercial Manufacturing Documentation team. Facilitate and coordinate Manufacturing records review to meet batch disposition timelines, preparation and review of Cleaning Verification Packs, PRIMR data entry and management of...
...domestic and foreign currency
Using 2 and 3-way Purchase Orders
Vendor Account analysis and account reconciliation
Vendor statement review and reconciliation
Providing customer service to internal and external clients
Taking care of global vendors, foreign currency,...
...issues with plant equipment issues and associated systems, identifying and recommending corrective actions
Assisting in the design review, site acceptance and installation of equipment
Supporting QA Validation department by preparation of design documents and assisting...