Quality Control Associate | BioNJ Talent Services

Quality Control Associate

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

Amicus Therapeutics (Nasdaq:FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases.

With one rare disease medicine globally commercialized for Fabry disease, an investigational enzyme replacement therapy (AT-GAA) in late stage development for the treatment of Pompe disease, and a robust gene therapy pipeline and growth platform for lysosomal storage disorders, Amicus Therapeutics is committed to changing the lives of people with these life-threatening conditions.

Job Description:

Summary of Position

The QC Associate will review and compare documents including (but not limited to) clinical and regulatory submission documents, clinical study reports, and protocols versus source documents for accuracy, content, grammar, consistency, formatting, and compliance to local guidance. 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.

Role and Responsibilities

The QC Associate is responsible for:
Understanding statistical data listings, tables, and figures to ensure they are incorporated into the written document and interpreted appropriately.
Verifying written document against source data in clinical study reports and regulatory submission documents.
Assisting in the resolution of comments from Quality Assurance.
Participating in cross-functional interactions with medical writing, QA, regulatory, Pharmacovigilance, statistics, and clinical teams.
Reports to Quality Control Manager

Qualifications: 

Qualifications and Background Requirements

Bachelor of Science degree, or equivalent experience plus a minimum of 5 years of industry experience in a QC role.

Professional Work Experience
A minimum of 5 years of QC experience for a pharmaceutical company is preferred.
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 Tables, Listings, and Figures; eCTD (Common Technical Document); and clinical operations procedures.
This position requires computer skills such as Word, Excel, and Power Point.
The applicant would have previous experience in reviewing statistically generated Tables, Listings, and Figures; reviewed clinical study reports; and submission documents.
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 and Regulatory Inspections.
The applicant must be able to communicate with other functional groups for the documents needed (such as source documents) in order to perform a 100% QC.

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Quality Control