Quality Assurance Analyst

Lyndhurst, NJ
Mar 14, 2018
Required Education
Bachelors Degree
Position Type
Full time

Company Background/Culture


The company is a private equity sponsored, growth stage, specialty generic pharmaceutical organization focused on the development, manufacture and sale of products for the U.S. market with a secondary focus on international market(s), currently China.

The company strategy is to pursue the development of products that are challenging to formulate, manufacture and/or have a combination of barriers to market entry. The company’s differentiated formulation capability is one key of several elements of the company’s strategy.

Specific Duties


  • Ensure the QC and development laboratories are compliant with GMP regulations, USP Pharmacopeia and ICH standards
  • Provide quality review of batch records and laboratory documents including raw data, specifications, SOPs, test methods, methods validation/verification documents and stability protocol/reports
  • Ensure site adherence to Quality systems with a focus on laboratory compliance to all specifications, analytical SOP’s, ICH and appropriate standards.
  • Assist the Quality Assurance Manager with tracking all complaints, deviations, change controls, CAPA, etc. to ensure timely closure
  • Review OOS investigations and other laboratory incidents including deviations; and evaluate resulting CAPA’s and change proposals. Assures that incidents and investigations are properly investigated and resolved.  
  • Review analytical technology transfer and method validation
  • Reviews stability protocol and data reports  
  • Participate in quality process improvement initiatives and project teams
  • Interact with operations/laboratories to provide quality perspective on processes and support systems. 
  • Performs additional tasks as required.


Professional Experience/Qualifications


3-5years Quality assurance/Quality Control experience in the pharmaceutical industry

Personal Characteristics


Self-motivator, excellent time management and organizational skills, good inter-personal skills



BS Degree or MS Degree (preferably in chemistry) with 3- 5 years of relevant experience in the pharmaceutical industry



Competitive base salary that recognizes the importance of this position