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Labs Data Reviewer (GMP, Biopharmaceutical)

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<p style="text-align:left"><b>Work Schedule</b></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p><p><b>Job Title:</b> Labs Data Reviewer</p><div><div><div><p><b>Details:</b> Fully remote, full time</p><p><b>Department:</b> Biopharmaceutical</p></div><div><p></p><p><i><span><span>This is a fully</span><span> remote</span><span> role </span><span>supporting </span><span>our GMP Lab</span> <span>in Middleton, Wisconsin</span></span><span><span>. We welcome applicants from all locations within the US. </span> <span>Must be legally authorized to work in the United States without sponsorship.</span> <span>Must be able to pass a comprehensive background check, which includes a drug screening.</span></span><span> </span></i></p><p></p><p>At Thermo Fisher Scientific, 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 make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond 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 through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.</p><p></p><p>Our PPD® Laboratory Services team has a direct impact 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 quality to deliver groundbreaking innovations!</p><p></p><h2><b>Discover Impactful Work:</b></h2><p>The Data Reviewer performs review of a variety of routine and complex 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, Standard Operating Procedures (SOPs) acceptance criteria, and Good Manufacturing Practices (GMP). Reviews data entered into databases and reports and monitors the quality of the laboratory data. Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis review independently.</p><p></p><h2><b>A Day in the Life:</b></h2><ul><li><p>Evaluates laboratory data for compliance with analytical methods, client directives, and SOPs.</p></li><li><p>Reviews sample results for scientific soundness, completeness, accurate representation of the data, and final reported results.</p></li><li><p>Communicates with laboratory staff to proactively maintain the quality of laboratory documentation.</p></li><li><p>Delivers review findings noting deficiencies within the analytical data or reports in a clear and concise manner.</p></li><li><p>Escalate significant deficiencies to the project leader or supervisor for assessment.</p></li><li><p>Facilitates in conversations with lab staff on best documentation practices and addressing quality findings.</p></li><li><p>Advocates for quality and review process changes.</p></li><li><p>Identifies and supports process improvement initiatives.</p></li><li><p>Performs other duties as assigned.</p></li></ul><p></p><h2><b>Keys to Success:</b></h2><p><u>Education</u></p><ul><li><p>Bachelor's degree or equivalent and relevant formal academic / vocational qualification</p></li></ul><p></p><p><u>Experience</u></p><ul><li><p>Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).</p></li></ul><p></p><p><i>In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role</i></p><p></p><p><b>Knowledge, Skills, Abilities</b></p><ul><li><p><span>Demonstrated experience of HPLC data review and Empower strongly preferred</span></p></li><li><p><span>Previous experience with in GMP </span><span>regulated laboratory environment</span><span> preferred</span> <span>strongly preferred</span></p></li><li><p>Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP</p></li><li><p>Thorough knowledge of chromatography.</p></li><li><p>To demonstrate behaviors which align to the 4i Values of Thermo Fisher</p></li><li><p>Strong technical knowledge including an understanding of laboratory procedures, methodology, and standards</p></li><li><p>Strong verbal and written communication skills</p></li><li><p>Strong attention to detail</p></li><li><p>Ability to balance time and remain focused on work to meet goals</p></li><li><p>Ability to train staff on basic review techniques</p></li><li><p>Ability to independently review laboratory reports and analytical methods</p></li><li><p>Ability to deal with multiple and changing priorities</p></li><li><p>Ability to provide clear and concise feedback and/or documentation of results</p></li><li><p>Ability to work in a collaborative team environment</p></li><li><p>Ability to work efficiently in a remote capacity</p></li></ul><p></p><p><b>Work Environment</b><br>Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the <span><span><span><span><span><span><span><span><span><span><span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">working environment/requirements for</span></span></span></span></span></span></span></span></span></span></span></span> this role:</p><ul><li><p>Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.</p></li><li><p>Able to work upright and stationary and/or standing for typical working hours.</p></li><li><p>Able to lift and move objects up to 25 pounds.</p></li><li><p>Able to work in non-traditional work environments.</p></li><li><p>Able to use and learn standard office equipment and technology with proficiency.</p></li><li><p>May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.</p></li><li><p>Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.</p></li></ul><p></p><p>Our Mission is to enable our customers to make 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 share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.</p></div></div><p></p><p>Apply today! <a href="http://jobs.thermofisher.com/" target="_blank" rel="noopener noreferrer"><span><span><span><span><span><span><span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">http://jobs.thermofisher.com</span></span></span></span></span></span></span></span></a></p><p></p><p>Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.</p><p></p><p><span><b><span><span><span><span><span><span><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">Accessibility/Disability</span></span></span></span></span></span></span></b></span><b> Access</b></p><p>Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.</p><p></p><p>*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.</p></div><p></p><p></p><p></p><p></p><p></p>

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...

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