cGxPServe

Job Description: Design develop integrate test evaluate or improve integrated systems or related processes primarily with human factors quality control inventory control and material flow cost analysis and production coordination. Must work with manufacturing personnel quality labs s More...

Responsibilities: Prepares and/or coordinate CMC activities for new product registrations post approval changes renewals annual reports and extension applications ensuring on-time and high-quality global submissions. Interface with external Contract Manufacturing Organizations (CMO) More...

Responsibilities: Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions. Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations. Revi More...

Job description: The QC Analyst is responsible for performing tasks associated with release testing and reviewing laboratory data and for supporting internal & external partners of the QC organization. Responsibilities: Support QA QC and AS&T teams. Ensure on time and GMP-compliant r More...

Job Description: We are seeking an experienced Project Manager to join our team for a critical project at our Holly Springs location. This role requires individuals with a strong background in CQV (Commissioning Qualification and Validation) and experience in commissioning and onboard More...

Responsibilities: Main responsibility includes design of Case Report Forms development of edit check specifications creation of test scripts and testing of study database query processing data reporting putting in place data management plans timelines and manage multiple projects thr More...

Responsibilities: Performing data manipulation analysis and reporting of clinical trial data for both safety and efficacy (ISS/Client) utilizing SAS programming. Generating and validating SDTM and Adam datasets/analysis files and tables listings and figures (TLFs). Production and QC More...

Job Description: We are seeking a Packaging Operator to execute packaging and labelling processes per Batch Record requirements in accordance with cGMP guidelines. This role includes documentation cleaning equipment setup and collaboration across departments to maintain production com More...

Roles & Responsibilities: Lead PFMEA activities with cross-functional teams. Participate in DFM and DFA for new product development. Develop manufacturing assembly and test methods. Requires a bachelors degree. Must have experience in the medical device field. Requires 5 years in an More...

Responsibilities: Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Creates revises and implements quality standards as well as procedures i.e. Standard Operating Procedures (SOPs) etc. for Erbe USAs Quality Management Sy More...

Responsibilities: Providing statistical programming support to generate tables listings and figures for assigned projects. Demonstrating proficiency in CDISC SDTM and Adam to support various submission activities including IA CSR DSUR and publications. Overseeing all aspects of stati More...

Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe support of international product registrations and related regulatory affairs activities including execution of procedures and More...

Responsibilities: Support day-to-day medical device manufacturing operations ensuring compliance with FDA QSR and ISO 13485 standards. Lead and execute equipment qualifications (IQ/OQ) and process validations (OQ/PQ) including cleaning and upgrade validations. Perform process charact More...

Responsibilities: Lead and manage change control processes for S/4HANA implementation in alignment with GxP and related SOPs. Review project timelines to ensure sufficient time is allocated for GxP validation activities and documentation deliverables. Prepare and maintain validation More...

Responsibilities: Maintain and update EDC user access across multiple clinical studies. Track and manage user access requests in coordination with CRAs and EDC vendors. Curate and maintain standardized tracking spreadsheets for both internal and external use Transfer verified data fr More...

Responsibilities: Responsible for performing various Quality Engineering activities whose main purpose is to facilitate continuous improvement for both products and processes and to support new product/process development activities. These activities include process validation defect More...

Job Description: We are seeking a Systems or Quality Engineer to be responsible for integrating design procedures templates and guidance documents within our ISO 13485 compliant Quality Management System (QMS). The successful candidate will have a working knowledge of FDA/ISO regulati More...

Roles & Responsibilities: Manufacturing Expert with good process knowledge. Work closely with R&D team and define the manufacturing process that more suites for the process for the NPI programs. Come up with cost optimization ideation and ease the manufacturing process. Guide the More...

Job Description: Seeking a Contract Scientist to support the siRNA group within the Biotherapeutics and Genetic Medicine (BGM) department. This temporary position offers the opportunity to contribute to the design and execution of cutting-edge experimental approaches to address key sc More...

Roles & Responsibilities: Candidate must have understating on latest regulations i.e. 21CFR Part 11 EU annex 11 and Guidelines e.g. GAMP5 guide. Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Well versed with Manufacturing Quality More...