What are the responsibilities and job description for the Administrator I, Document Control QA position at QPS Holdings, LLC?
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 Stage Clinical and Phase I IV Clinical Research services. We welcome individuals who want to be part of our growing organization. QPS is an innovative, dynamic organization that strives to employ talented, caring and committed employees who will work collaboratively towards achieving our mission of improving human health and the quality of life. QPS offers challenging and rewarding work in its four core business areas and support functions. Underpinning the operation is a culture that values diversity, innovation and accountability. Employees are encouraged to take responsibility and achieve their best, both as individuals and as team members.
Description
The Administrator I, Document Control in the Quality Assurance Department serves as an administrator of essential documents and ensures respective lifecycles and document control. This position will maintain the Quality Management System document infrastructure and changes thereof in order to comply with regulations set forth for Good Clinical Practice, Good Manufacturing Practice, and electronic records/electronic signatures. Incumbent ensures company documents and deliverables are kept controlled, organized, protected, and secured for internal and external compliance reviews. This position independently manages activities and works frequently with authors, reviewers and managers to continually maintain document quality, regulatory compliance, and an optimal operational environment.
Responsibilities
QPS is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. QPS prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. QPS conforms to the spirit as well as to the letter of all applicable laws and regulations.
Description
The Administrator I, Document Control in the Quality Assurance Department serves as an administrator of essential documents and ensures respective lifecycles and document control. This position will maintain the Quality Management System document infrastructure and changes thereof in order to comply with regulations set forth for Good Clinical Practice, Good Manufacturing Practice, and electronic records/electronic signatures. Incumbent ensures company documents and deliverables are kept controlled, organized, protected, and secured for internal and external compliance reviews. This position independently manages activities and works frequently with authors, reviewers and managers to continually maintain document quality, regulatory compliance, and an optimal operational environment.
Responsibilities
- Prevent breach of confidentiality and/or personal data in all aspects of work.
- Control, protect and secure essential company documents
- Navigate electronic network folders and physical records storage and administer secure portal software.
- Ensure complete tasks, timely deliverables and workload balance.
- Act as a supportive source of knowledge for quality policies and procedures.
- Participate in management meetings to convey document status and needs.
- Ensure support and secure management of deliverables for customer and agency audits and inspections.
- Facilitate a respectful and friendly atmosphere in the workplace.
- Plan and prioritize tasks, projects and realistic goals according to set timelines.
- Promote quality performance and improvements throughout the organization.
- Ensure professional, clear and prompt verbal and written communications.
- Utilize available software and database(s) to track activities, documents and time ‑ allocation.
- Participate after hours when necessary to meet life-cycle timelines.
- Act as document administrator of essential documents (e.g., policies, procedures, forms, manuals, templates).
- Ensure document life-cycle management (creation to retirement), change-control and historical records.
- University/College Degree in relevant Scientific discipline, and/or
- Demonstrated experience administering essential documents
- Demonstrated proficiency in technical writing preferred
- Retirement Savings Plan
- Paid Vacation
- Paid Holidays
- Paid Sick Time
- Personal Days
- Employee Assistance Program
- Life Insurance
- Health, Dental, Vision
- Long Term Disability Insurance
- Other Benefits
QPS is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. QPS prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. QPS conforms to the spirit as well as to the letter of all applicable laws and regulations.
