job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation. location: Cambridge, Massachusetts job type: Contract salary: $28.64 - 33.69 per hour work hours: 9 to 5 education: Bachelors responsibilities: Maintains and develops effective documentation systems appropriate for a research setting.Coordinates and ensures appropriate documentation for the Vaccine Research and Analytics laboratory.Facilitate and oversee the coordination, planning, assembly, writing, editing, and quality control of written research findings (reports, abstracts, manuscripts, systematic reviews, presentations, etc.) or regulatory documents (protocols, investigator brochures, study reports, etc.). Ensure data and reports are in compliance with regulatory standards, applicable SOPs, policies, procedures.Work with authors/technical specialists to coordinate the completion of specialized content, to translate, write, edit and/or proof data and content (exhibits, illustrations, tables, and appendices) for publication into finished documents appropriate for the stated audience. Participate in quality control review for documents written by other authors when requested.Write and review standard operating procedures (SOPs), laboratory procedures, equipment instructions, knowledge- based documents and business policies.Generate document templates and laboratory and equipment logs for general use.Manage templates and document versions in an electronic document management system (EDMS).Manage documents and training in a learning management system (LMS), to help plan, deliver and assess competencies.Develop an archiving plan and prepare records for archving in an electronic records management system (ERMS).Submit data and reports to Regulatory for inclusion in dossiers.Train technical staff and management in quality and documentation procedures, including good documentation practices, handling and review of electronic laboratory notebooks, data and reports. qualifications: B.S degree in a scientific disciplineAt least 6 years laboratory experience, preferably in a clinical testing or analytical laboratory, Quality, or R&DMust have excellent written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy.Must have experience working in a GXP environmentMust have experience writing and reviewing technical documentation, ideally have experience with advanced functions of Microsoft Word.Experience working in a GXP environment is preferred.Familiarity with regulatory processing and submissions is desirable.Experience with Electronic Document and Learning Management Systems is desirable.Experience working with and training cross functional groups. Must be creatively open to new ideas and methods and work with a spirit of continuous improvement and innovation.Ability to identify, report, and seek prompt corrections as they arise.Manual dexterity required to operate office equipment (i.e. computers, phones, etc.). skills: SOP, MS-WORD, MS-EXCEL, MS-Powerpoint, LIMS (Laboratory Information Management System Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.