...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...
...Summary: Provides support to the process for creating, reviewing, approving, distributing, controlling and maintaining documentation to ensure effective and efficient application of GMP.
Documentation within this process includes, but is not limited to, manufacturing and...
Within 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...
Within this role you will be responsible for managing and overseeing Document Control and Archives operations. This includes oversight of the following: document workflows, records issuance, paper and electronic records archives, inspection support, projects, and metrics....
...and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
As a QA Specialist or Sr Specialist a typical day might include... ...Performing area walkthroughs
Providing oversight and review of documentation for non-routine work such as Area in PAAS, Incursions...
...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 by providing...
...and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
Essential Duties and Responsibilities include, but are not limited... ...following:
Responsible for all aspects of QA Team including review and approval of the following types of documents, relating to...
...but is not limited to, the following:
Authoring and peer reviewing of failure investigations/deviations relating to QC operations... ...employees
Increasing responsibilities for authoring and reviewing documents/ data
Compliance representation and participation in cross...
...may include, but are not limited to, the following.
Responsible for ensuring that all documentation (SOPs, Manufacturing Records, Batch Sheets & Logbooks) is current, accurate, reviewed and in accordance with regulatory requirements.
Leads, motivates, and manages the...
...Key person for technical input into Manufacturing records, batch sheets and procedures.
Writes, reviews, Standard Operating Procedures or other controlled documents as needed.
Provides technical input to resolve process problems both on and off the production suites...
...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 in Life...
...Ensures, in collaboration with the team, the timely routing and review of all technical transfer activities, validation plans, master... ...records (MRs), standard operating procedures (SOPs) and other documentation needed to successfully complete required clinical and commercial...
...process equipment and manufacturing
Assisting in the design review, site acceptance and installation of equipment
Preparing piping... ...Supporting QA Validation department by preparation of design documents and assisting in protocol execution
Assisting in investigations...
...role
Performing equipment cleaning, preparation and execution as well as completing associated documentation
Performing various tests and in-process sampling
Reviewing, editing and revising completed batch records, Logbooks, and SOPs in accordance with cGMP standards...
...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 operating...
...solutions or recommendations for changes and/or improvements.
Reviews, edits, and approves deviation notifications, deviation... ..., edits, and approves change controls, SOPs, reports and other documentation.
Coordinates with other departments or outside contractors/vendors...
...include, but is not limited to, the following:
Coordination and documentation of QC quality records including but not limited to, Change... ...Control/CAPA events and align team on approach forward
Reviewing, editing, and revising controlled documents ( logbooks, SOPs,...
...business process owner and users
Responsible for IT Applications documentation, including, converting User Requirement Specifications to a... ...Applications systems security access and periodic audit trail reviews
Other duties as assigned
This role may be for you if you...
...ambiguity into actional steps. Ensure appropriate communications between IOPS and global RA in a timely manner
• Review the content and format of regulatory filing documents (e.g. pre-INDs, INDs, IMPDs, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements, scientific...
...operations of off-site manufacturing. This role is responsible for reviewing process data to ensure operational consistency after the... ...equipment readiness, analytical process transfer, manufacturing document creation, etc.
Reviewing and approving cGMP batch documentation...
...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 in protocol execution
Assisting in investigations of...
...troubleshooting activities associated with the manufacturing process
Supports technology transfer activities as needed
Reviews Manufacturing documentation associated with the transferred process
To be considered for this opportunity you should have a BS/BA in Life...
...quality program.
In this role a typical day might include, but is not limited to, the following :
Gathering data and documenting test results
Reviewing test results to ensure compliance with standards; reporting any quality anomalies
Complying with all pertinent...
...strategy
Thinking critically, troubleshooting proactively and solving complex problems
Experiencing review requirements, specifications and technical design documents to provide timely and meaningful feedback
Producing detailed documentation to a high standard
This...
...global projects aimed at harmonizing laboratory data system
Reviewing updates to regulatory guidelines for electronic data systems to... ...Requirement Specifications (FRSs) with current formats
Reviewing documents and ensure consistency with SOPs and current formats...
...Acting as a Technical SME/Lead on initiatives
Managing system documentation tasks, including converting User Requirement Specifications to... ...Applications systems security access and periodic audit trail reviews
Supporting day to day activities for IT Applications
Providing...
...Technical Writing assistance with the creation/updating of GxP Documents
Providing Technical Writing assistance with the management of... ...Technical Writing assistance with the completion of System Periodic Reviews.
Supporting the execution of System Audit Trail Reviews...
...process materials, or stability samples in support of the company’s quality program.
Capturing data and documenting test results.
Completing test records and reviewing data.
Calibrating or verifying calibration of instruments/devices prior to use.
Reviewing test...
This position implements policies and procedures to review and approve validation/qualification documentation for equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards, and oversees a team of Validation Oversight Specialists...
...Additionally, the individual processes system change controls, documents and maintains configurations to ensure that the MES remains in a... ...Functionality Specifications, and Configuration Specifications
Reviews company documentation including SOPs, Batch Sheets and/or...