Data Review Specialist – Extractables and Leachable

Job Description

You'll be crucial in ensuring clients receive quality data by meticulously reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations . Essential Duties and Responsibilities Apply GMP/GLP in all areas of responsibility, as appropriate. Demonstrate and promote the company vision. Ensure regular attendance and punctuality. Read and understand analytical procedures. Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs. Gain a technical understanding of the techniques for which review is being performed. Use MS Windows applications such as Excel, Word, Access, and Outlook email. Conduct all activities in a safe and efficient manner. Perform other duties as assigned. Qualifications Education/Experience: Master's degree in a science-related field (Biochemistry / Biotechnology / Microbiology) with 3-7 years of experience in Bio/Pharmaceutical drug product/substance testing with knowledge of regulatory requirements. Experience with analytical techniques such as qPCR, microbiological techniques, knowledge of USP/EP/JP compendia , and laboratory software applications such as PCR analysis software, bioinformatics tools, and LIMS is preferred. Key Candidate Attributes Self-motivation ; excellent quality of work and attention to detail. Ability to communicate effectively with coworkers and internal/external clients. Ability to learn new tasks quickly and to move easily from task to task. Ability to handle prioritization and multiple tasks simultaneously . Ability to use a personal computer and learn necessary programs. Good communication skills (oral and written). Organizational ability and good judgment. Science background/education and/or laboratory experience. Strong Math Skills. Logical Thinking, Good Reasoning Ability. Motivation to excel. Coaching/mentoring of peers.