DOCUMENTATION SUPERVISOR Argos Therapeutics

SCOPE:
Plan, develop, and implement the activities of the Document Management and Control Department, which maintains designated cGMP documents and document management processes

RESPONSIBILITIES:
? Supervise, coordinate, and prioritize the daily activities of the Document Management and Control Department.
? Exercise judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
? Provide technical expertise concerning document management to all areas of the company and solve problems as they arise.
? Over-see and assist with the maintenance of applicable regulatory and other relevant master/ control documents and logs.
? Plan, develop, implement, and enforce document management policies for the company to support research, IND submissions, and manufacturing activities, and ensure compliance with document management regulatory concerns.
? Develop and enforce practices within the Document Management and Control Department to maintain a thorough and organized, centralized document management system, which will standardize filing, protecting, retrieving records, reports, and other information contained on paper, computer programs, or other media ? Supervise the periodic review and provide status reports of approved documents to ensure compliance with internal criteria.
? Perform and over-see non-technical review and editing of new and revised documents.
? Working together with the IT Department, manage the selection and implementation of new or updated documentation management systems.
? As applicable, serve as the administrator of document management electronic system(s)
? Conduct employee counseling, performance evaluations, new hire interviews, etc.
? Perform general management activities for the department, such as establishing and monitoring departmental goals.
? Participate in FDA-driven audits by providing documentation and consultation as needed.
? Assist Document Management and Control staff with daily activities and special projects as needed.
? Manage off-site inventory as required.
? Perform other related activities as required.

QUALIFICATIONS:
? Bachelors degree with 8+ years related experience in pharmaceutical/biopharmaceutical industry, which includes document management experience, or equivalent combination of education and experience.
? Demonstrated strong communication skills, both written and verbal.
? Ability to deal with problems involving several concrete variables in standardized solutions: ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
? Ability and desire to respond professionally to common and/or sensitive inquiries or complaints from internal/external customers or regulatory agencies.
? Strong, effective organizational skills required; detail oriented; ability to multi-task.
? Demonstrated, effective leadership abilities required.
? Must be able to successfully work across functional areas and interface with area management.
? Computer literate with experience in Microsoft Office, SharePoint, Visio, and Adobe Acrobat.
? Proficient grammar skills which reflect a strong aptitude for reviewing documents from a grammatical perspective.
? Ability and willingness to be regularly, predictably and reliably at work.

Location:	4233 Technology Drive Durham, NC 27704 United States