Quality Control Specialist

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 Quality Control Specialist is an entry-level position within the functions of the Quality Control Department, including the maintenance of trial-related source documents, as well as the timely reporting of clinical data to clients and/or regulatory authorities. The Quality Control Specialist must possess strong time management skills in order to effectively compile and manage source documents, perform data entry, QC source documents and transcribed data, participate in client interaction and requests, and perform short term or long-term projects as required by the department manager and/or department supervisor within contractual timelines.

Responsibilities:

• Develop a full understanding of Standard Operating Procedures, study protocols and data entry guidelines for multiple clinical trials and effectively organize study specific information for efficient recall.
• Perform all department tasks within pre-defined contractual timelines and according to Standard Operating Procedures, study protocols, and data entry guidelines.
• Compile and interpret data gathered from clinical trials in order to accurately transcribe the data into paper or electronic case report forms.
• 100% review of all source documents and case report forms in order to analyze, identify, query and resolve data issues and inconsistencies, ensuring quality-reporting standards are met through an established Quality Control process.
• Customer service, including effective communication with other staff and/or clients regarding client visit preparation, client requests and assisting with the completion of both internal and external queries in a timely manner.
• Audit the contents of all source document folders after trial completion to ensure completeness and accuracy, assisting with resolution of any issues prior to archiving the study files.
• Source document organization, management and filing.
• Duties may include more than what is listed and are subject to change without prior notice

QUALIFICATIONS:

• High school diploma / GED required
• Previous data management and Microsoft Office experience desired (at least 6 months)
• Good time management, organizational and interpersonal skills
• Good written and oral communication
• Ability to work independently and as a team
• Consistency in delivering positive results, following through with tasks from start to finish

EEO Minorities/Females/Protected Veterans/Disabled

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.