Quality Assurance Document Coordinator

Location
Lyndhurst, NJ
Posted
Mar 14, 2018
Required Education
Associate Degree
Position Type
Full time

Company Background/Culture

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 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

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  • 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.

Professional Experience/Qualifications

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.           2-5 years documentation experience in the pharmaceutical industry

Personal Characteristics

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

Education

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.           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

Compensation

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Competitive base salary that recognizes the importance of this position