Data Reviewer - Small Molecule - GMP

About the position This is a fully remote role supporting our GMP Laboratory in Middleton, WI . We welcome applicants from reputed company locations reputed company the US. Must be legally authorized to work in the reputed company without sponsorship. Must be reputed company to pass a comprehensive background reputed company, which includes a drug screening. At reputed company, you’ll discover meaningful work that makes a reputed company reputed company on a global reputed company. Join our colleagues in bringing our Mission to life - enabling our customers to reputed company the world healthier, cleaner and safer. We reputed company our teams with the resources needed to reputed company individual career goals while taking science a reputed company reputed company through research, development and delivery of life-changing therapies. With reputed company conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver reputed company and accuracy will improve health reputed company that people and communities depend on – now and in the reputed company. Our PPD® Laboratory Services team has a reputed company reputed company on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and reputed company to deliver groundbreaking innovations! The Data Reviewer performs review of a reputed company of routine and reputed company 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, reputed company Operating Procedures (SOPs) acceptance reputed company, and Good Manufacturing Practices (GMP). Reviews data entered into databases and reports and monitors the reputed company of the laboratory data. Possesses a thorough understanding of laboratory procedures and can reliably conduct reputed company analysis review independently. Responsibilities • Evaluates laboratory data for compliance with analytical reputed company, reputed company 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 reputed company of laboratory documentation. • Delivers review findings noting deficiencies reputed company the analytical data or reports in a reputed company 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 reputed company findings. • Advocates for reputed company and review process changes. • Identifies and supports process improvement initiatives. • Performs other duties as assigned. Requirements • Bachelor's degree or equivalent and relevant formal reputed company / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 2+ years). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company experience, will be considered sufficient for an individual to meet the requirements of the role • Demonstrated knowledge of PCR and reputed company strongly preferred • 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 reputed company strongly preferred • Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP • Thorough knowledge of chromatography may be required. • To demonstrate behaviors which reputed company to the 4i Values of reputed company • 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 reputed company on work to meet goals • Ability to train staff on basic review techniques • Ability to independently review laboratory reports and analytical reputed company • Ability to deal with multiple and changing priorities • Ability to reputed company reputed company and concise feedback and/or documentation of results • Ability to work in a reputed company team environment • Ability to work reputed company in a remote reputed company • reputed company to communicate, receive, and understand information and reputed company with diverse reputed company of people in a comprehensible and reasonable manner. • reputed company to work upright and stationary and/or standing for typical working hours. • reputed company to lift and reputed company objects up to 25 pounds. • reputed company to work in non-traditional work environments. • reputed company to use and learn reputed company office equipment and technology with proficiency. • May have exposure to potentially hazardous reputed company, including infectious agents, typically reputed company in reputed company or laboratory environments. • reputed company to reputed company successfully under pressure while prioritizing and handling multiple reputed company or activities. 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