Senior Document Control Specialist

At 10x Genomics, accelerating our understanding of biology is more than a mission for us. It is a commitment. This is the century of biology, and the breakthroughs we make now have the potential to change the world.We enable scientists to advance their research, allowing them to address scientific questions they did not even know they could ask. Our tools have enabled fundamental discoveries across biology including cancer, immunology, and neuroscience.Our teams are empowered and encouraged to follow their passions, pursue new ideas, and perform at their best in an inclusive and dynamic environment. We know that behind every scientific breakthrough, there is a deep infrastructure of talented people driving the life sciences industry and making it possible for scientists and clinicians to make new strides. We are dedicated to finding the very best person for every aspect of our work because the innovations and discoveries that we enable together will lead to better technologies, better treatments, and a better future. Find out how you can make a 10x difference. About the role:We are seeking a Senior Document Control Specialist to be responsible for managing documentation and records generated during various processes according to the organization’s process control for commercial and operations functions. The ideal candidate will work closely with Production and R&D teams to support new product introduction, production batch records change control and BOM setup in the electronic documentation and ERP systems. What you will be doing:Process document changes (ECO), engineering change requests (ECR) and record retention policies.Perform documentation content review and edit files originated by subject matter experts.Support document support for NPI launches and responsible for documentation and label deliverables to meet project timelines.Print and track label stocks; perform basic maintenance and troubleshoot of printing equipment.Design and control manufacturing labels; print batch record and labels for manufacturing.Expert in document review; Write packaging production batch records. Conduct system training for PLM users on ECO workflow, quality processes and maintaining training records.Coordinate/ administrate PLM and documentation systems training.Perform other quality related duties as assigned.To be successful, you will need:5+ years of document control experience2+ years working in Life Sciences or Bio-Pharmaceutical industries Working knowledge of cGMP, ISO standards and quality management systemsWorking knowledge of ERP/PLM system integrationStrong written and verbal communication skills and process.Experienced with internal, external auditing programs with great attention to detail.Self-starter, detail oriented, quick learner, problem-solverDegree in Sciences preferred#LI-MH1Individuals seeking employment at 10x Genomics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. 10x does not accept unsolicited applicants submitted by third-party recruiters or agencies. Any resume or application submitted to 10x without a vendor agreement in place will be considered unsolicited and property of 10x, and 10x will not pay a placement fee.