Analytical Chemistry Technical Data Reviewer
About The Position
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description: Primary focus on review of standardized testing and custom studies: o Familiar with the concepts and data outputs of various analytical instrumentation including but not limited to: GCMS, LCMS, ICP, SEM-EDS, DSC, FTIR, DLS, particle counts and wet chemistry. o Verifies electronic data and written raw data to ensure accuracy and completeness of testing documentation according to methods, protocols/study designs, and /or SOPs. o Ensures compliance to GDP/GMP expectations. o Reviews routine/standard and custom final analysis reports and verifies the integrity and traceability of data reported. o Performs verification of calculations via hand-calculations, computers, or validated spreadsheets. o Understands and references USP Participates in spreadsheet validation activities as needed. Ability to present issues supported by solid rationale and evidence; collaborate and suggest solutions to enforce compliance. Manage work queue and prioritize to meet customer timelines. Interacts with technical study managers, project managers, and technical staff as required. Able to navigate electronic systems (e.g. LIMS, environmental monitoring, Chromatographic Data Systems) to verify electronic data. Facilitates corrections with analysts to ensure all records are complete and accurate. Assist in SOP revisions as needed or required. Assist in education, guiding and influencing scientific staff in regards GDP best practices. Assist in mentoring and training new data reviewers as needed. Other duties as assigned.
Requirements
- Minimum 1 year of review or quality control experience preferred
- Bachelor’s Degree in scientific field or related discipline
- Minimum 3 years’ experience working in a regulated environment
- Need to be able to read, write and understand English
- Proficient in Microsoft (Excel, Word, Outlook)
- The ability to work in a fast-paced environment while managing priorities and maintaining deadlines for multiple projects.
Nice To Haves
- Life Science and/or Biotech laboratory experience preferred
- Analytical chemistry / chromatography experience preferred
- Strong organizational skills with attention to detail
- Proficient in Oral & Written communication skills
Responsibilities
- Familiar with the concepts and data outputs of various analytical instrumentation including but not limited to: GCMS, LCMS, ICP, SEM-EDS, DSC, FTIR, DLS, particle counts and wet chemistry.
- Verifies electronic data and written raw data to ensure accuracy and completeness of testing documentation according to methods, protocols/study designs, and /or SOPs.
- Ensures compliance to GDP/GMP expectations.
- Reviews routine/standard and custom final analysis reports and verifies the integrity and traceability of data reported.
- Performs verification of calculations via hand-calculations, computers, or validated spreadsheets.
- Understands and references USP
- Participates in spreadsheet validation activities as needed.
- Ability to present issues supported by solid rationale and evidence; collaborate and suggest solutions to enforce compliance.
- Manage work queue and prioritize to meet customer timelines.
- Interacts with technical study managers, project managers, and technical staff as required.
- Able to navigate electronic systems (e.g. LIMS, environmental monitoring, Chromatographic Data Systems) to verify electronic data.
- Facilitates corrections with analysts to ensure all records are complete and accurate.
- Assist in SOP revisions as needed or required.
- Assist in education, guiding and influencing scientific staff in regards GDP best practices.
- Assist in mentoring and training new data reviewers as needed.
- Other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
