Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you! The Senior Specialist, Document Finishing is a key contributor within the Laboratory and Compliance Management (LCM) in the Department of Translational Medicine (TLM). The candidate will be responsible for the smooth document finishing process of TLM study reports by exercising independent judgement and initiative in developing submission ready reports. Additionally, the Document Specialist will be trained to be a potential back-up to the TLM QA Calendar Scheduler to ensure that TLM requested QA Audits are scheduled efficiently to meet client due dates.
The successful candidate will perform document finishing assignments by ensuring TLM study reports are consistent with pharmaceutical industry standards, FDA Guidelines, electronic submission guidelines as well as TLM’s Document Finishing Policy and QPS Standard Operating Procedures. Clear communication via email and in person, prioritization skills, and great attention to detail are beneficial to successfully manage the QA Calendar Schedule and move the reports through the document finishing process.
This role requires comfort working in Microsoft Word and Excel as well as Adobe Acrobat Software. Time management and multitasking skills are essential to this role. There are multiple daily interactions with TLM Operations teams as well as QA Auditors; excellent communication skills and ability to follow up is required.
QPS’ Story:
Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Phase Clinical and Phase II – IV Clinical Research services. To meet the needs of our clients, we strive to employ talented, caring and committed individuals who will work collaboratively towards achieving our mission of improving human health and the quality of life.
Team members enjoy challenging and rewarding work, and are encouraged achieve their best. Underpinning the operation is a culture that values diversity, innovation, accountability, team work and a friendly atmosphere where performance is recognized and rewarded. We provide unique company benefits, training, and advancement opportunities. Most importantly, we value each of our team members as employees and as individuals.
If this sounds like your ideal work environment, then we would love to speak with you, so apply today!
Please visit our website (www.qps.com) for more information and to see all current openings.
The Job
Become comfortable with utilizing QPS or Client Templates, generate GLP and Non-GLP final PDF Reports for clients.Follow the document finishing process from start to finishBecome familiar with identifying formatting discrepancies within reportsInteract with other document finishing team members to resolve identified discrepancies/issues.Help to ensure reports meet submission ready requirements per checklists and guidelines.Comply with company policies, SOPs and GLP regulations.Ability to multitask and work independentlyMaintain consistent, accurate, and up-to-date notes.Self-review completed work for accuracy, consistency, focus and adherence to format and stylistic requirements in order to ensure high quality documents.Help to address any document changes required from feedback from supervisor, Operations, or clients.Help monitor Report Finishing Request Log multiple times daily for updates and added requests.
Work Location
This job will be 100% QPS-office/facility based
Requirements
Education / Experience
Combination of relevant education & experience that provides sufficient knowledge & skills to ensure incumbent’s success in this role, such as: University/College Degree in relevant Scientific discipline, and/or Demonstrated experience in CRO, Clinical Research, or other relevant field. Experience in a Regulated industry laboratory preferred
Why You Should Apply
Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals.Structured Career Ladders that provide excellent growth based on your personal aspirations.Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance.Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability InsurancePark-like setting in Newark, DelawareInternal committees designed with the needs and enjoyment of QPS employees in mind.
QPS, LLC is an Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.