Administrator, Document Control
Administrator, Document Control
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Job Description
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! Incumbent performs various administrative duties with integrity and ensures all QPS records and business affairs assigned to them are kept in a confidential manner. Tasks assigned serve to ensure company records are kept controlled organized protected and secured for internal and external compliance reviews. Incumbent serves as a Subject Matter Expert on respective document control tasks and as qualified may also conduct audits for professional growth and maximizing audit capacity.
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 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 () for more information and to see all current openings.
The Job
- Maintain personal integrity and client confidentiality in all job-aspects.
- Ensure QPS documents received to manage tasks are kept controlled protected and secured.
- Support working teams by retrieving and converting documents into digital format (e.g. PDF).
- Save digital documents to appropriate project folders using consistent file naming conventions.
- Perform quality control checks to ensure accurate legible and complete digital documents and folders.
- Maintain organized current and accurate files and folders (paper and electronic).
- Support QA Host to facilitate external audits and inspections (e.g. client consultant US FDA).
- Administer secure portal for external virtual reviewers (e.g. iDeals Virtual Data Room ).
- Correspond with client and Agency representatives in regards to fulfilling deliverable requests.
- Provide only authorized deliverables to support QPS Host in facilitating external reviewer requests.
- Prepare Master Schedule copy and redacts thereof per QA Host for external audits and inspections.
- Perform monthly Master Schedule tasks and provide statistics to QA management.
- Per SOP Administrator maintain current SOP binder set assigned to Quality Assurance.
- Perform year-end Quality Assurance administrative tasks to ensure QA records maintenance.
- Archive Quality Assurance records for secure historical retention and evidence of completed tasks.
- Travel to Newark Delaware QPS facilities as needed to retrieve/return company documents.
- Attend training seminars as directed by line management.
- Keep current on policy and procedure reviews as directed by line management.
- As qualified and priorities and line management permit conduct QA system or study audits such as:
- Facility process suppliers Employee Qualification Manuals study-specific trace-back deviation form reviews and processing etc.
- Log work hours into company system (e.g. ADP) and obtain overtime pre-approval from management.
- Provide additional administrative tasks as supported or directed by management.
Work Location
- This job will be 100% QPS-office/facility based
Requirements
- High school diploma college certificate Associates or Bachelors degree.
- One (1) year working in a regulatory environment (GLP GCP or GMP).
- Proficient in Microsoft Outlook Word Excel PowerPoint and Adobe.
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 Insurance
- Park-like setting in Newark Delaware
- Internal 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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
