Quality Assurance Document Maintenance Specialist

Norwich Pharmaceuticals Inc • Norwich, NY

2d • $0 - $62,354 • Onsite

About The Position

The Document Maintenance Specialist scans and maintains electronic records, including 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.

Requirements

• Associate degree and experience in Technical, Life Science, or Business environments.
• 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.

Nice To Haves

• 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.

Responsibilities

• 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.
• 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.

Benefits

• medical and prescription drug coverage (two PPO plans and an HDHP with Health Savings Account and employer contribution)
• dental
• vision
• flexible spending accounts
• 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
• 13 company recognized paid holidays per year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree