Job Openings

Regulatory Affairs and Quality Assurance Specialist
January 26,2021
Fairfield NJ

Job Description:

  • Ensure the organization meets all the applicable guidelines and regulation established by FDA, cGMP and ICH.
  • Prepare, complete and authenticate documents with FDA for the Abbreviated New Drug Application.
  • Perform quality management practices including Total Quality Management (TQM), and continuous quality management to monitor pharmaceutical process.
  • Participate in investigation of quality related product complaints. Participate in executing validation protocols for products, process and facilities to assure quality attributes for the company.

Requirements:

  • Master’s in Pharmacy or related. 
  • Resume to support@granulationtech.com
Address: 12 Industrial Rd, Fairfield, NJ 07004

Chemist, Analytical Development

January 26,2021

Fairfield NJ

Job Description:

  • Support drug product development including API, excipient and intermediate characterization.
  • Develop, validate and transfer analytical methods for products using HPLC, GC, UPLC, GC, Malvern particle sizer, Differential Scanning Calorimetry.
  • Work with Quality and Regulatory department to meet project technical document requirements.
  • Prepare method validation protocols, validation reports & new SOPs applicable to new projects. 

Requirements:

  • Master’s in Chemistry or related + min 1 year related experience
  • Resume to support@granulationtech.com

Address: 12 Industrial Rd, Fairfield, NJ 07004

Quality Control Laboratory Manager

July 11,2020

Fairfield, NJ

Job Description:

  • Oversee the Quality Control team on day-to-day functions involving the release of products for manufacturing.
  • Train the Chemist and Analyst to perform their jobs in correct and compliant manner.
  • Review and approve the deviations involved in laboratory investigations.
  • Review and approve documents relevant to Method Validation, Method Transfer, Process Validation, Cleaning Validations and Stability Program.

Requirements:

  • Master’s in Chemistry or Pharmaceutical Sciences.
  • 1 year experience in job offered or 1 year experience as Chemist, QC Analyst or any suitable combination of experience/education/ training.
  • Resume to support@granulationtech.com

Hours:

  • 9 AM to 5 PM, 40 hours/Week

Salary:

  • $86,000/Year

Address: 12 Industrial Rd, Fairfield, NJ 07004

 
QC Chemist
Jan 13,2019
Fairfield NJ

Job Description:

  • Analyze Raw material, packaging components, in-process & finished products utilizing HPLC, UPLC, Dissolution Apparatus, IR/FTIR, GC.
  • Provide regulatory support re QC related activities.
  • Record and maintain QC Reference Standards & HPLC Columns.
  • Assist in validation testing activities of dosage forms & API per USP, ICH guidelines &/or in-house protocols.
  • Assist in updating & mainting control copy of SOPs, Training Records & Safety practices.
  • Ensure on-line/good documentation practices for each lab activity.
  • Maintain collaboration status of QC instruments..

Requirements:

  • Masters in Pharmaceutical sciences or related.
  • Resume to support@granulationtech.com
Address: 12 Industrial Rd, Fairfield, NJ 07004