Associate, Quality Documentation

Orexigen Therapeutics - Morristown, NJ

Full-time - Mid Level

Morristown, NJ

Chemical Manufacturing

About the position

The Quality Assurance Associate will support quality assurance and related regulatory compliance for the company with responsibilities and duties described below and as assigned by the Director-Quality Assurance and company leadership as applicable.

Responsibilities

• Support quality review and maintenance of GXP-controlled documents including, but not limited to, SOPs, specifications, test methods, change controls, and product labeling
• Administer and maintain SOPs for GXP compliance including periodic review
• Manage the administration and operation of electronic document management systems (EDMS) and/or shared drive content as applicable for GXP compliance including timely processing of controlled documents within EDMS where needed
• Contribute to timely completion of company quality metrics
• Support product complaint processing and review
• Support product disposition processing and review
• Lend support to regulatory inspections of the company when needed
• Contribute to management and processing of vendor audits as necessary
• Contribute to timely review of vendor documents for product quality assurance

Requirements

• Bachelor's or Associate of Arts/Sciences degree or equivalent experience
• A minimum of 5 years relevant pharmaceutical industry experience including the following:
• Experience with 21 CFR 210 / 211 compliance and quality system requirements
• Experience in implementing and maintaining GXP document management systems
• Experience managing quality assurance and/or quality control in a pharmaceutical company
• Experience managing GXP compliance associated with commercial pharmaceutical products
• Proven ability to complete assignments and tasks in a timely and effective manner in a regulated environment. Attention to detail, follow through, and organizational skills
• Excellent oral and written communication skills. Ability to communicate across multiple levels of management and cross-functional areas
• Excellent analytical and problem-solving skills
• Must be self-directed and highly motivated
• Willingness and ability to travel (10%)

Benefits

• medical, dental, and vision coverage
• 401(k) plan with company match
• paid time off and holidays
• other benefits to support your physical, financial, and social well-being