Lab Systems Master Data Administrator Full Time, Temporary $42/hr Remote Kelly Services is currently seeking a Lab Systems Master Data Admin position for one of our top clients in Raynham, MA. Remote is fine for right candidate - Kelly Outsourcing Consulting Group KellyOCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Lab Systems Master Data Admin for a long-term engagement at one of our Global clients in Raynham, MA. This role is a full-time, fully benefited position. - As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. - You’ll also be eligible for paid time off, including holiday, vacation and sick/personal time. - All KellyOCG employees receive annual performance reviews. **MUST HAVE LABVANTAGE EXPERTISE As a Lab Systems Master Data Admin placed with KellyOCG you will be responsible for the following: The Laboratory Systems Master Data Admin is responsible for the configuration, testing, validation, and administration of business data within laboratory applications. The Laboratory Systems Master Data Admin will work with laboratory SMEs and application Product Owners to understand requirements for configuration of master data elements such as templates, test methods, and data flows within laboratory systems. The Laboratory Systems Master Data Admin will be responsible for following change control processes, documenting change details, defining test cases, performing testing, and implementing changes for master data elements to meet validation requirements. The Laboratory Systems Master Data Admin will be responsible for end user communication support and training of applicable topics to laboratory SMEs to facilitate system use. The Laboratory Systems Master Data Admin will be responsible for ensuring accurate and up to date master data within laboratory applications including instrument, consumable, fixture, test method, instrument integration handlers, instrument data parsing scripts, and other types of master data. Responsibilities: - Performs configuration work within laboratory systems (ie ELN, LIMS, data management) - Documents change rationales, implementation strategies, and monitors changes - Defines test cases for validation of configured objects as required per change control procedures - Administration & maintenance of master data elements within laboratory systems (ie ELN, LIMS) - Liaise with laboratory SME & application product owner to determine best implementations for configuration - Assist users with troubleshooting laboratory applications - Assist with training users of laboratory applications Experience/Education: - Bachelor’s Degree required, preferably in an Engineering, Science, IT, or related field. - Minimum of 2 years’ experience in a regulated industry. - Experience with software validation processes and principles, specifically of configured elements within a regulated software environment. - The ability to review and critically assess processes. - Strong analytical skills, especially in the areas of process improvement, problem solving, and logical thinking is required. - Ability to work unsupervised on assigned tasks. - Strong attention to detail, demonstrated enthusiasm and willingness to learn. - Must be highly organized, able to work on concurrent projects and meet tight deadlines. - Ability to coordinate & communicate with external partners/vendors in a timely manner. - Preferred: - Experience with Jira. - Experience with laboratory information management systems (LIMS) or electronic laboratory notebooks (ELN) (e.g., Labvantage, Labware, Biovia, etc) - Experience with Material Data Management Systems (MDMS) (e.g., Granta MI) - Experience with Agile project management techniques.

Role Description This is a fully remote role supporting our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US. - Must be legally authorized to work in the United States without sponsorship. - Must be able to pass a comprehensive background check, which includes a drug screening. The Data Reviewer performs review of a variety of routine and complex analytical analysis experiments that are conducted on pharmaceutical and biopharmaceutical compounds with various formulations and/or biological matrices. Ensures analyses are following validated or experimental analytical procedures, and compare results to methodology, protocol and product specifications, Standard Operating Procedures (SOPs) acceptance criteria, and Good Manufacturing Practices (GMP). Reviews data entered into databases and reports and monitors the quality of the laboratory data. Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis review independently. A Day in the Life: - Evaluates laboratory data for compliance with analytical methods, client directives, and SOPs. - Reviews sample results for scientific soundness, completeness, accurate representation of the data, and final reported results. - Communicates with laboratory staff to proactively maintain the quality of laboratory documentation. - Delivers review findings noting deficiencies within the analytical data or reports in a clear and concise manner. - Escalate significant deficiencies to the project leader or supervisor for assessment. - Facilitates in conversations with lab staff on best documentation practices and addressing quality findings. - Advocates for quality and review process changes. - Identifies and supports process improvement initiatives. - Performs other duties as assigned. Qualifications - Bachelor's degree or equivalent and relevant formal academic/vocational qualification. - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). - In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Requirements - Previous experience with formal data review in GMP Lab strongly preferred. - Previous experience with method validation or method validation data review strongly preferred. - Previous experience with chromatographic review and Empower strongly preferred. - Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP. - Thorough knowledge of chromatography may be required. - Strong technical knowledge including an understanding of laboratory procedures, methodology, and standards. - Strong verbal and written communication skills. - Strong attention to detail. - Ability to balance time and remain focused on work to meet goals. - Ability to train staff on basic review techniques. - Ability to independently review laboratory reports and analytical methods. - Ability to deal with multiple and changing priorities. - Ability to provide clear and concise feedback and/or documentation of results. - Ability to work in a collaborative team environment. - Ability to work efficiently in a remote capacity. Benefits - Thermo Fisher Scientific values the health and wellbeing of our employees. - Support and encourage individuals to create a healthy and balanced environment where they can thrive.

• Enter and update support contract data in ERP, CRM, or contract management systems. • Establish, link, and maintain customer assets under support contracts, ensuring accurate relationships between serial numbers, product IDs, and contract terms. • Verify contract start and end dates, coverage levels, and entitlements for each asset. • Perform periodic audits of data to ensure alignment between contracts, service records, and billing systems. • Process contract renewals, amendments, cancellations, and terminations according to approved procedures. • Collaborate with operations to resolve discrepancies in asset or contract data. • Maintain accurate digital and physical records following company data governance policies. • Generate reports and dashboards to support KPI tracking (e.g., contract coverage rates, active asset counts). • Support process improvements that enhance data quality and system integration related to contracts and assets. • Monitor, manage, and respond to email inquiries in shared mailboxes.

Role Description The Director of Product Engineering will lead the strategy and development of our Data Management Products. This role is pivotal in shaping innovative solutions that meet the evolving needs of our clients in the life science sector. The successful candidate will bridge the gap between technology and business, ensuring our products not only excel in functionality but also in market relevance and user satisfaction. Success in this role means delivering products that are at the forefront of industry standards, driving user engagement, and achieving strategic business goals. We’re looking for a Product Director with deep industry expertise in Data Management that support global clinical trials. In this role, you’ll drive the strategy, development, and delivery of data-centric products that power innovation in life sciences. If you're experienced in Technology, Data Management, Agile SAFe methodologies and thrive in cross-functional environments, we’d love to connect. Join us in transforming clinical development through technology, agility, and purpose-driven solutions. The Product Director will lead the strategy and development of our data management software. This role is pivotal in shaping innovative solutions that meet the evolving needs of our clients in the life science sector. The successful candidate will bridge the gap between technology and business, ensuring our products not only excel in functionality but also in market relevance and user satisfaction. Success in this role means delivering products that are at the forefront of industry standards, driving user engagement, and achieving strategic business goals. - Lead the overall product life cycle from conception to launch, aligning product vision with customer needs and business goals, for multiple products. - Conduct market research and analysis to identify trends, opportunities, and competitive threats in the life sciences sector. - Conduct market research to identify vendors available in this space and analytically decide between build vs. buy. - Define (hands-on) and prioritize product requirements, features, and functionalities in collaboration with data management operations teams, engineering, data and other teams. - Develop and maintain product roadmaps, ensuring clear communication and alignment across all stakeholders. - Monitor and evaluate product performance metrics, adjusting strategies as necessary to achieve success. - Foster strong relationships with key clients and industry experts to gather insights and feedback for continuous product improvement. - Ensure compliance with industry regulations and standards. - Manage products like a business owner, owning portfolio forecasts, budget management, status reporting and driving efficiency into teams and utilization of resourcing including consumption of licenses and 3rd party spend. - Oversee support teams responsible for the Data management incident, problem and change management processes. - Manage all other duties as needed or assigned, ensuring flexibility and adaptability to changing business needs. Qualifications - Bachelor’s degree in engineering, Life Sciences, Health Care, or a related field. - Extensive experience working on standard EDC products like Medidata, Veeva, CTMS and other similar systems. - Knowledge of CDISC, ICH frameworks and keeps track of recent changes and advancements. - Experience of understanding data concepts for data management systems and Business Intelligence products. - Fortrea may consider relevant and equivalent experience in lieu of educational requirements. - Proficiency in product management tools and methodologies (including DevOps). - Exceptional analytical, strategic thinking, and problem-solving skills. - Excellent communication and interpersonal skills, capable of working effectively with cross functional teams. Requirements - At least 12+ years of experience in product management within the life sciences (data management particularly) and product development industry. - Experience in developing and launching software products in the Data Management and Biostatistics areas. - Proven track record of managing all aspects of a successful product throughout its lifecycle. - Experience with Agile Methodologies. - Experience with managing globally diverse matrixed teams. - Leadership and interpersonal skills, with a focus on empathy and building collaborative relationships. - Knowledge of GxP, CSV and highly regulated environments requirements. Preferred Qualifications/Experience - Advanced degree (MBA or equivalent) in Business, Life Sciences, or related field. - Prior experience in a startup or a fast-paced environment, or in Ops Data Management with technical acumen. - Certification in Product Management or Agile methodologies. - Strong understanding of data management processes within the CRO industry. - Strong technical background with understanding of software development processes. - Demonstrated ability to think creatively and strategically when solving problems and making decisions. Learn more about our EEO & Accommodations request here.