cGxPServe

Job Description: The Quality Assurance team within the Worldwide Operations Manufacturing department is seeking an enthusiastic results-oriented and experienced Quality Assurance Specialist to join our organization as a Remote Worker. The candidate will be responsible for supporting More...

Responsibilities: The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS) Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products including regulatory responsibilities in associated change control an More...

Responsibilities: Provide leadership strategic planning direction and implementation of clinical systems for data collection which may include vendor selection budgeting resource planning vendor oversight EDC build and study timelines etc. Perform or provide oversight to staff for al More...

Responsibilities: Preparing documentation for international regulatory registrations. Preparing technical documentation compliant to MDD and EU MDR. Defining worldwide regulatory requirements necessary for regulatory approval of products. Participating on cross functional teams as re More...

Responsibilities: Assist in the development testing and validation of Electronic Data Capture (EDC) systems and Case Report Forms (CRFs). Support database setup activities including edit check specifications and user acceptance testing (UAT). Review incoming clinical data for complet More...

Responsibilities: Regulatory / V&V / Quality Assurance Engineer with 10-14 Years of experience. Knowledge of Design History file Device History Record and Device Master Record documents. Proficiency in Project management and execution. 3-6 years of experience in DHF gap analysis / re More...

Job Description: Our client is currently building (started in 2024) a 125000 sq ft greenfield manufacturing facility outside of Pittsburgh PA. Expected to be operational by 2027 Q1. The electricity gets turned on in this facility in the end of Jan 2026. The facility will be state of More...

Requirements: Review and support design verification protocols and test reports. Ensure compliance with internal design verification design control equipment control and risk management procedures. Assist cross-functional teams to complete design verification activities on time. Guid More...

Responsibilities: Lead the creation of the Data Review and Cleaning Plan and development of the data cleaning strategy. Provide oversight of the data validation plan and provide DM insight to maximize the data validation strategy. Review CRFs to ensure alignment with protocol; lead a More...

Responsibilities: Design code and test SAS programs used to generate CDISC SDTM & ADaM domains and tables listings & figures outputs. Perform analyses defined in the statistical analysis plan as well as ad hoc analyses as requested. Validate CDISC SDTM and ADaM data sets by using Ope More...

Job Description: This section focuses on the main purpose of the job in one to four sentences. Technical lead for DHF structure within sustaining engineering for disposable medical devices. Responsibilities: This section contains a list of primary responsibilities of this role that a More...

Responsibilities: Responsible for the oversight of all data management CRO activities supporting companys clinical programs from database start-up through database lock and CSR/submission. Serves as primary point of contact with the DM CROs 3rd party vendors and internal study More...

Job Description: The Data Manager Data Management Oncology Early Development (OED) is a member of the Data Management and Analysis team responsible for supporting the successful delivery of data and processes conducted by CROs. This individual will collaborate closely with the Data Ma More...

Responsibilities: Review and validate vendor-provided system documentation for serialization/track & trace systems (e.g. Optel Systech Trace Link). Develop and execute a risk-based validation strategy aligned with company and regulatory standards. Create or refine UAT scripts execute More...

Responsibilities: Under the direction of the applicable management the Clinical Data Manager (CDM) is responsible for executing end to end data management activities pertaining to clinical trials including but not limited to; data management tool and system development validation and More...

Responsibilities: The Senior Manager of Statistical Programming is a leadership role which manages a team of statistical programmers in the research and development of new pharmaceutical products. The Senior Manager of Statistical Programming is responsible for leading the statistica More...

Responsibilities: Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of companies products. This section cont More...

Job Description: We are seeking to add top talent to our Materials Support team. The Material Handler performs operations of the Supply Chain/Materials Management department with awareness and knowledge of the various areas of the operations in Goods Receipt Goods Issue Warehousing In More...

Responsibilities: Regulatory Labelling Documentation. Support the creation and maintenance of assigned labelling projects to enable worldwide regulatory submissions. Independently prepare and maintain the Tracking Sheets for the global regulatory dossiers related to labelling project More...

Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies guidelines and procedures. Develops protocols and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validat More...