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