QA Analyst

Sanaria - Frederick, MD

Full-time - Entry Level

Frederick, MD

Professional, Scientific, and Technical Services

About the position

Sanaria Inc. is seeking a highly organized Quality Assurance Analyst to manage and improve the quality system, programs, and procedures within a pharmaceutical manufacturing environment. The role involves interaction with the validation department and reviewing validation procedures and protocols, contributing to the company's mission of eradicating malaria through innovative vaccine development.

Responsibilities

• Manage Quality Management Systems (Deviations, CAPA, Change Control, OOS etc)
• Facilitator of Risk assessments
• Investigate complex incidents to draw out root cause and implement CAPAs
• Review raw data for GXP reporting
• Support the supplier qualification program
• Perform internal audits
• Administer GXP training
• Review Batch Record in support of product release
• Be one of the quality assurance point persons for manufacturing activities
• Perform room release in support of manufacturing activities
• Deliver Training for individuals/small group/large group training
• Participates in the execution, review and approval of qualification, validation activities

Requirements

• Bachelor's degree in a science-related field
• 2-4 years of experience in the pharmaceutical/medical device/diagnostic industry with progressively responsible experience
• Knowledge of US and EU GMP's
• Knowledge of USP and EP compendium
• Knowledge of aseptic and sterile product quality
• Strong communication, teamwork, attention to detail, initiative and project management skills
• Excellent written and oral English language skills
• Ability to work in a fast-paced environment with multiple and competing priorities
• Familiarity and aptitude with Microsoft Word, Microsoft Excel, and Adobe PDF

Nice-to-haves

• Demonstrated success in leading investigations and problem resolution
• Work with the QA Team to assure continuous improvement of the Quality Management System
• Demonstrated interest and ability to manage technical and operational aspects of the team
• Demonstrated ability to apply cGMP expectations
• Prior involvement in QA and experience in biologics/vaccines

Benefits

• Company paid life and disability insurance
• Health plans with employee and dependent subsidy
• 401k plan with company match