quality documentation specialist.

job summary: A Quality Control Documentation Specialist is needed for a leader in developing and providing healthcare in the Lexington, MA area. The ideal candidate will possess strong interpersonal communication skills, the ability to work well in a team setting, as well as independently. This individual must be detail oriented and able to meet deadlines while working with limited oversight.   location: Lexington, Massachusetts job type: Contract salary: $20.57 - 32.05 per hour work hours: 8am to 5pm education: Bachelors   responsibilities: Primary Duties of this position will focus on creation and maintenance of documents to support the operations of the QC Raw Materials laboratory.Documents created and maintained may include protocols, risk assessments, reports, standard operating procedures, and methods.This position is expected to maintain operational and GMP readiness of the QC areas. In addition, the individual may participate in more complex projects, operational excellence initiatives, laboratory operation activities and quality systems with supervision. Education/Experience: Normally requires a Bachelor's degree in the field; 3 - 5 years of experience   qualifications: Experience level: ExperiencedEducation: Bachelors  skills: QualityPharmaceutical 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.

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.

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: $34.88 - 41.03 per hour work hours: 9 to 5 education: Bachelors   responsibilities: The Analyst, Cell Therapies QC Microbiology is responsible for the performance of microbiological related activities at the Cell Therapies Manufacturing Facility in Cambridge.This position is responsible to assist in all microbiological related activities needed in the in-house GMP cell therapies production of investigational new drugs from development, transfer, (re-)qualification, (re-)validation to routine performance activities. Primary responsibilities: (80%) Perform environmental monitoring (viable particle monitoring -air, settle plates, contact plates as well as non-viable particulate monitoring) of the Cell Therapies Manufacturing Facility in Cambridge.Perform plate reading and Data entry/verification of the test results.Perform RODI sampling.Responsible for shipping and tracking samples and test results.Participate in environmental monitoring performance (re-)qualifications and aseptic process (re-)validations.Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.Keep the Microbiology lab clean, safe and tidy all the time. Secondary responsibilities: (20%) Perform gowning qualifications for personnel needing access to the internal GMP facility.Perform growth promotion tests.Assist in release testing (Sterility, Endotoxin and Mycoplasma) related to microbiology as needed to support the manufacturing of investigational new cell therapy drug products manufactured in the internal GMP facility in Cambridge.Assist in the EM investigations per SOP.Other Micro support as needed.  qualifications: Bachelor's Degree in Microbiology or another relevant fieldMinimum of 1-2 years' experience in the bio/pharmaceutical industryMinimum of 1-2 years' experience in GMP QC Microbiology laboratoryExperience in performing environmental monitoring in GMP cleanrooms (Grade A-C)Experience in gowning qualification and aseptic techniquesMicrobiology knowledge and practical experience of microbiology testingExperience using MODA is a plusExcellent organizational, communication, and interpersonal skillsIn general, the position requires a combination of sedentary work and standing for extended periods of time in the microbiology laboratory and gowned up in the cleanrooms.This role supports pharmaceutical production operations therefore the work environment includes exposure to production and cell processing facilities, packaging, component printing and analytical laboratories (this list is not exhaustive).  skills: Quality control, SOP, GMP (Good Manufacturing Practice) 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.