Quality Assurance Associate

Location: Andover, MA
Job Code: 164
# of openings: 1

Description

SUMMARY OF POSITION: 

 

This position is one which requires a strong technical background, a high degree of enthusiasm, enjoyment of working in a fast paced environment, being self-motivated, and being able to use critical reasoning to solve problems and make decisions. Updates logs, databases and catalogues. Coordinates the review and revision of procedures, forms and policies.  Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness.  Assists in compiling audit preparation documents and maintaining computerized files to support all documentation systems.Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.  Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.  Normally receives no instructions on routine work, general instructions and supervision on new assignments. 

 

 

PRIMARY RESPONSIBILITIES:

  • Work with a document/training management system and author supporting written standard operating procedures to meet organizational needs

  • Manage an on-site controlled/limited access document archive

  • Manage processes of off-site commercial document archiving vendor

  • Process, maintain and control  documentation (policies, procedures, forms, reports, manuals, etc.) supporting internal departments and external vendors as required by the current Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP) regulations and as required by International Standards

  • Review documents to determine distribution requirements and process distribution requests according to set procedures

  • Organize filing systems for hard-copy and electronic documents

  • Perform data entry for tracking documents and specimens

  • Provide information, data, reports, meeting packets, and briefings in support of informal and formal meetings and management review

  • Provide support for maintenance and continuous improvement of Ora’s Quality Management Systems (QMS), including but not limited to Internal/External Audit preparation, processing of documentation for Deviations, Equipment Identification and Calibration records, Vendor Qualifications, Equipment Validations, and Quality Agreements

  • Provide QA support of Clinical Labeling Operations and shipment of Investigational Product to clinical trial sites

  • Perform other Quality Assurance related duties as assigned

 

 

 

REQUIRED SKILLS AND ATTRIBUTES:

  • Must be able to demonstrate through prior work experience familiarity with the clinical trial process.

  • A minimum of 2-5 years of document control experience working within a regulated environment. 

  • Ability to work well in a team environment, have a strong commitment to the accomplishment of tasks, can follow procedures, and has the initiative to identify opportunities for improvements and the inter-personal skills to promote and accomplish constructive solutions to problems.

  • Competency in Microsoft Office applications including Excel

  • Ability to work in a fast-paced environment

  • Attention to detail with emphasis on accuracy and quality

  • Ability to prioritize work to balance multiple projects and deadlines

  • Excellent verbal and written communication skills

  • Exceptional customer service skills

OTHER REQUIREMENTS:

  • Experience working with document management/training software applications strongly desired

  • Experience working with Microsoft applications

  • Experience creating electronic forms

  • Experience in other areas of GXP/GCP Quality Assurance





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