Lead Quality Control Associate (Contract) | BioNJ Talent Services

Lead Quality Control Associate (Contract)

Contact Information
Contact Name: 
Amicus Therapeutics
Organization Name: 
Amicus Therapeutics
Position Location: 
Cranbury
Company Profile: 

Amicus Therapeutics, Inc. (Nasdaq:FOLD) is a global biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We have a robust development pipeline of treatments for a range of human genetic diseases.

Our lead product candidate, migalastat, is a personalized medicine in late-stage development to treat individuals with Fabry disease on the basis of their genetic diagnosis. SD-101, a product candidate in late-stage development, is a potential first-to-market therapy for the rare genetic connective tissue disorder Epidermolysis Bullosa (EB). We are leveraging our biologics and Chaperone-Advanced Replacement Therapy (CHART™) platform technologies to develop novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other Lysosomal Storage Disorders (LSDs). Our lead biologics program is ATB200/AT2221, a uniquely engineered Pompe disease ERT that will be administered in combination with a pharmacological chaperone.

Job Description:

Position Summary

The Lead QC Associate Contractor will review and compare clinical, regulatory submission documents, clinical study reports, protocols, versus source documents for accuracy, content, formatting and compliance to local guidance’s. Examples of source documents are as follows: statistical tables/listings/figures, clinical study reports, statistical analysis plans, references, Amicus style guide and local regulatory guidance’s. The Lead QC Associate Contractor will also be involved in the writing, revising and reviewing of Standard Operating Procedures (SOPs) across functional groups. This will include becoming proficient with our document control management system, MasterControl, as the associate will be responsible for guiding documents through the document approval process. In addition, the associate may interact with vendors regarding Trial Master Files (TMFs) or in relation to any other services the vendor is providing.

Roles and Responsibilities
Understanding statistical data-listings, tables and figures to ensure they are incorporated and interpreted appropriately into the written document.
Verifying source data to written document in clinical study reports and regulatory submission documents.
Assisting in the resolution of comments from Quality Assurance.
Cross functional interactions include medical writing, QA, regulatory, Pharmacovigilance, statistics and clinical teams.
Writing, revising and reviewing SOPs

Qualifications: 

Requirements
BS Degree, or equivalent experience plus a minimum of 5 year’s industry experience in a QC role.
The ideal applicant would have GCP training, particularly in areas such as data reporting and clinical trial management, as well as experience in written communication.
A good understanding of GCP, study Table, Listings and Figures, eCTD (Common Technical Document) and clinical operations procedures.
A minimum of 5 years of QC experience for a pharmaceutical company is preferred.
The applicant would have previous experience in reviewing statistically generated Tables, Listings and Figures, reviewed clinical study reports and submission documents.

Experience and Skills
This position requires computer skills, such as Word, Excel and Power Point.
Applicant must be able to communicate well with cross functional areas such as medical writing, regulatory, data management and statistics.
This individual will also support the clinical operations functions in responding to Quality Control Audits, Regulatory Inspections.
The applicant must be able to communicate with other functional groups on the documents needed, such as source documents, in order to perform a 100% QC.

Travel
0-5%

Additional Job or Internship Information
Position Type: 
Contract
Function: 
Clinical Operations