Pay: $65,000-$75,000
Effectively encourage and motivate associates to be successful and remain focused on Quality, Transparency, Safety and Availability objectives compatible with the company’s mission and vision. Responsible for providing oversight of Quality System elements, including managing control of documents (SOPs, WI, Specifications, Batch Records, etc.) that impact the identity, strength, quality, and purity of finished product, and providing support on Quality management projects.
Maintain the document control program in MasterControl to ensure procedures meet CGMP requirements as a Document Administrator
Organize, file, and maintain record storage, including off-site storage
Issue CGMP documents including Master Batch Production Records, Room and Equipment Logs, etc.
Participate in internal audits to ensure compliance with CGMP regulations and internal procedures
Support external inspections by regulatory bodies and customers by procuring documents and records for review
Manage training documentation and records
Develop and implement corrective and preventive actions geared toward continuous process improvements
Write and implement standard operating procedures to meet and maintain FDA CGMP, USP, and state licensure requirements
Other duties and tasks, as assigned

REQUIREMENTS:
2-5 years of Quality Assurance experience
Pharmaceutical, Medical Device, or biotechnology industry experience
B.S. or B.A. in Sciences or a relevant field or equivalent experience
High proficiency in using Microsoft Word, Excel, Power Point, Outlook
Professional certification in Quality Engineering or Quality Auditing, preferred

Excellent independent judgement and interpersonal skills
Excellent written and verbal communication skills
Strong technical writing skills and attention to detail
Familiarity with Good Manufacturing Practices and FDA Regulations