Job: Quality Assurance Document Coordinator

Title Quality Assurance Document Coordinator
Categories Quality
Reporting To SVP, Quality
Location Lyndhurst, New Jersey
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.

Specific Responsibilities
  • 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 8 years or more experience in the pharmaceutical industry
  • BA/BS Degree with 5 years or more experience in the pharmaceutical industry
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