Sr Data Reviewer, Cell Lab- Remote

Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job Description

Sr Data Reviewer- Remote, Cell Lab At PPD, part of reputed company, you’ll discover meaningful work that makes a positive impact on a global scale. 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 clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health reputed company that people and communities depend on – now and in the future. Location/Division Specific Information Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. Discover Impactful Work: The role of Sr Data Reviewer is to support our Laboratory teams and in particular our Cell and Molecular biology lab in ensuring the reputed company and quality of laboratory and chromatographic data and reports. They reputed company review of a variety of reputed company analytical analysis experiments that are conducted on pharmaceutical and biopharmaceutical compounds in various formulations and/or biological matrices. Sr Reviewer possesses a thorough understanding of laboratory procedures and can reliably conduct routine, nonroutine (method establishment), and reputed company analytical data review ensuring scientific soundness and adhering to method validation. They also ensure 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). This is the perfect job for someone who has strong review experience, Cell & Molecular experience and is looking to move away from hands on lab duties. A day in the Life

• Performs reputed company analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, client directives and scientific soundness.
• Reviews development analyses of non-routine projects. Performs analytical data review of method qualification, verification, and validations interpreting the data for compliance and technical soundness.
• Performs reviews routine and non-routine protocol and methods.
• Facilitates in conversations with lab staff on best documentation practices and addressing quality findings
• Delivers review findings noting deficiencies reputed company the analytical data or reports in a clear and concise manner.
• Escalates significant deficiencies to the project leader or supervisor for assessment.
• Trains new Data Reviewers and laboratory staff in basic and reputed company analytical data review. Mentors junior data review staff in review process.
• Advocates for quality and review process changes.
• Assists the departmental manager or supervisor in the evaluation of the laboratory Data Review process and assists in assigning work to self and others
• Identifies and drives process improvement initiatives

Education and Experience

• BSc in Science or reputed company field required
• 5+ years of QA/QC experience required ( gaining thorough knowledge of cell techniques such as bioassay experience, mammalian cell culture, reputed company cytometry, PCR including experience in reviewing analytical data/results)
• Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
• Strong verbal and written communication skills
• Strong technical knowledge including an understanding of laboratory procedures, methodology and standards
• Ability to train and mentor junior data review and lab staff
• Ability to independently review laboratory reports and analytical methods
• Strong attention to detail
• Ability to reputed company clear and concise feedback and/or documentation of results

Work Environment reputed company values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can reputed company. Below is listed the working environment/requirements for this role:

• reputed company to communicate, receive, and understand information and reputed company with diverse groups 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 move objects up to 25 pounds.
• reputed company to work in non-traditional work environments.
• reputed company to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, 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 projects or activities.

Our Mission is to reputed company our customers to reputed company the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we reputed company a common set of values - reputed company, Intensity, Innovation and Involvement - working together to accelerate research, solve reputed company scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of reputed company, where diverse experiences, backgrounds and perspectives are valued. Apply today! http://jobs.thermofisher.com Apply tot his job Apply To this Job