Quality Assurance Document Maintenance Specialist

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Regular Full-Time Norwich, NY, US

2 days ago Requisition

Salary: $62,354.00 Annually

The Document Maintenance Specialist scans and maintains electronic records (examples include, but are not limited to, Quality Assurance and Validation Documents). This role also supports document retention management and maintenance for both paper and electronic documentation. Other QA duties may be assigned by the direct manager based on priorities and business need.

The QA Document Maintenance Specialist reports directly to the Quality Assurance Manager, with a dotted line reporting to the Sr. Director of Operations and Pharmaceutical Technologies.

Primary responsibilities of this role include the following:

• Overall management of Document Maintenance (include: scanning, archival and retention management).
• Coordination of any third-party document management vendor activities.
• Scanning GMP documentation into the approved eQMS to ensure true copies of paper executed documents are backed up, accurate and available.
• This will include supporting both Quality Assurance and Validations departments.
• Assist with document maintenance activities as governed by the plant document retention procedure(s).
• Provide administrative and back-up support for other QA personnel as delegated by QA Management.
• Support FDA, external agency, internal, and customer audits as required by providing required documentation as requested by Quality Management.

• Associate degree and experience in Technical, Life Science, or Business environments. Minimum of 1-3 years experience in a Pharmaceutical or FDA regulated environment preferred.
• Knowledge of GMP, Quality systems, FDA/ICH guidance documents, and commonly-used concepts, practices, and procedures within the pharmaceutical industry is preferred.
• Strong organizational skills and ability to work independently.
• Knowledge and understanding of electronic document management systems.
• Strong written and oral communication skills, including the ability to work effectively with diverse groups of customers, management, and technicians. This includes the ability to work in a team environment.

Has the authority to manage, execute, and report on all aspects of the Document Maintenance administered programs. Additional approval authority may be designated by Quality Assurance Management as required.

The anticipated base Salary for this position is $62,354.00. This position is eligible for Alvogen’s annual discretionary bonus and comprehensive benefits package, consisting of medical and prescription drug coverage (two PPO plans and an HDHP with Health Savings Account and employer contribution), dental, vision, flexible spending accounts. Alvogen’s benefits package also includes a retirement savings program, long-term care coverage, paid time off (176 hours per year, prorated to hire date) inclusive of sick time, disability benefits, life insurance, a wellness program, and 13 company recognized paid holidays per year.