Sr Data Reviewer

From the original post

Job Overview Thermo Fisher Scientific is seeking a Sr Data Reviewer – Small Molecule for a fully remote position supporting their GMP Laboratory located in Middleton, WI. This role is primarily focused on conducting detailed reviews of analytical data related to pharmaceutical and biopharmaceutical compounds. Candidates can apply from anywhere in the USA, provided they are legally authorized to work in the country without sponsorship. This position requires passing a comprehensive background check, including a drug screening. Work Environment This role is designed to support a standard work schedule, usually Monday to Friday. The company adheres to all Good Manufacturing Practices (GMP) and safety standards. Employees are expected to maintain a balanced and healthy work environment, considering both physical and psychological well-being. Essential Responsibilities As a Sr Data Reviewer, key responsibilities include evaluating complex analytical data for compliance with established methods and ensuring scientific accuracy. The day-to-day tasks involve: Performing complex analytical data review for compliance with analytical methods, Standard Operating Procedures (SOPs), and client directives. Reviewing development analyses of non-routine projects, including method qualifications, verifications, and validations. Facilitating conversations with laboratory staff regarding best practices in documentation and addressing any quality findings. Delivering findings clearly, noting deficiencies in analytical data and escalating significant issues to project leaders or supervisors for assessment. Training and mentoring junior data review staff in both basic and complex analytical data review processes. Identifying and proposing process improvement initiatives to enhance operational efficiency. Skills and Qualifications To be successful in this role, applicants should possess a bachelor's degree or an equivalent qualification with substantial relevant experience—ideally 5+ years working in a similar role. Below are the key qualifications outlined by Thermo Fisher Scientific: Experience in formal data review within a GMP laboratory setting is strongly preferred. Deep understanding of SOPs and federal regulations, including GLP and GMP. Adequate knowledge in chromatography may be required. Strong technical acumen regarding method validation and evaluations of probable causes. Excellent communication skills (both verbal and written) and strong attention to detail. Ability to handle multiple priorities and work collaboratively within a team. Salary and Benefits While specific salary information for the Sr Data Reviewer position is not explicitly mentioned in the, roles in similar capacities within the pharmaceutical industry can expect competitive salaries commensurate with experience. Additionally, benefits usually include healthcare coverage, paid time off, and opportunities for professional development. Company Mission Thermo Fisher Scientific prides itself on making a positive impact on global health through its comprehensive portfolio in clinical research, including laboratory, digital, and decentralized services. They operate with a set of core values—Integrity, Intensity, Innovation, and Involvement—which guide their mission to assist customers in creating a healthier, cleaner, and safer world. The company emphasizes a collaborative work environment where diverse experiences are valued, encouraging employees to start their story with PPD, part of Thermo Fisher Scientific. Conclusion The Sr Data Reviewer position at Thermo Fisher Scientific presents an exciting opportunity for motivated individuals looking to further their careers in a dynamic environment that prioritizes scientific advancement and patient health. The role not only promises meaningful work but also offers ample resources for personal and professional growth. Interested candidates are encouraged to apply promptly, as the company seeks to expand its committed workforce. This job offer was originally published on jobicy.com.