Quality Assurance Analyst Ii, Gmp Biotech

Sanaria is a rapidly growing, multi-cultural, biotechnology company at the cutting edge of vaccine innovation. We are passionate about our goal to eradicate malaria. Sanaria employees are exceptional scientifically, mission-driven, and play a variety of roles in research, product development, manufacturing, clinical trials, and support of these endeavors. We offer a strong benefits package including company paid life and disability insurance, health plans with employee and dependent subsidy, and 401k plan with company match.

We are currently seeking a Quality Assurance Analyst with 2-4 years of experience. This position reports to the Quality Assurance Manager.

The position will be responsible for further developing and maintaining the quality system and developing Quality Assurance policies, programs and procedures for the company's clinical product, a novel malaria vaccine. This position will be responsible for defining processes or improving processes for receiving, manufacturing, packaging, testing and distribution for the clinical vaccine.

Primary 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

Additional Responsibilities

Participates in the execution, review and approval of qualification, validation activities

Preferred Requirements:

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

Knowledge in US 21CFR, EU GMP and relevant annexes and ICH guidelines.

Please send cover letter, resume and required pay rate to careers(at)sanaria.com, subject line “QA Analyst.” For more information, please visit www(dot)sanaria.com. Sanaria Inc. is an equal opportunity employer.

Job Type: Full-time

Pay: $52,000.00 - $62,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Work Location: In person