Quality Assurance Document Coordinator

Information

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.

SpecificResponsibilities

• Maintain all controlled documents both electronically and on the company’s intra-department server 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.
• Initiate internal Quality documentation such as deviations, change controls, CAPAs, etc and track them to ensure their timely closure;
• 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;
• Maintain a list of distributed documents, with the associated location and owner;
• Manage and develop document templates and formats that comply with government regulatory and company standards;
• Create Policies and SOPs as needed in conjunction with all internal departments.
• Assist with retrieval of documents as part of daily operations, management review meetings and other specified documents as needed,
• Providing guidance on document control practices and procedures to all departments;
• Aid in qualification of any newly implemented documentation and QMS systems.
• Perform additional tasks as needed.

Desired Skills &Experience

Professional Experience/Qualifications

• 5-10 years documentation and training experience in the pharmaceutical industry

Personal Characteristics

• Self-motivator, good time management skills, excellent organization skills, good inter-personal skills

Education

• HS Diploma with 10 years or more experience in the pharmaceutical industry
• AA/AS Degree with 8years or more experience in the pharmaceutical industry
• BA/BS Degree with 5 years or more experience in the pharmaceutical industry