Quality Assurance Document Coordinator
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.
- Maintain all controlled documents both electronically and manually in the QA document record center for US operations;
- Coordinate the archival and retention of all GMP related documentation.
- Develop and maintain databases for all Quality documentation and training for the US site.
- Assemble and review documents for completeness and accuracy and distribute to required reviewers/approvers;
- Assemble and distribute draft documents and training records for all affected departments;
- Manage and develop document templates and formats that comply with government regulatory and company standards;
- Assist in the creation of Policies and SOPs as needed, in conjunction with all internal departments and subject matter experts.
- Provide guidance on document control practices and procedures to all departments; including maintenance of list of distributed documents by location and owner
- Aid in qualification of any newly implemented documentation and QMS systems.
- Perform additional tasks as required.
. 2-5 years documentation experience in the pharmaceutical industry
Self-motivator, excellent time management and organizational skills, good inter-personal skills
. HS Diploma with 5 years of relevant experience in the pharmaceutical industry
AA/AS Degree with 2 - 3 years of relevant experience in the pharmaceutical industry
BA/BS Degree with 1 – 2 years of relevant experience in the pharmaceutical industry
Competitive base salary that recognizes the importance of this position