Biotech Quality Specialist

• Location: Dallas
• Type: Contract To Hire
• Job #38694

Rapidly growing Biotech Firm who manufactures injectables is now seeking a Quality Specialist responsible for supporting GMP manufacturing of raw materials and sterile drugs for clinical trials.

Summary of position
Quality Assurance Specialist supports GMP manufacturing of raw materials and sterile drugs for clinical trials. The individual in this role will review documentation related to raw materials, components, and completed batch records.  Individual will disposition raw materials, components, and products.  Assist with quality systems improvements.
Duties and responsibilities

• Oversee sterile manufacturing process, provide sterile gowning and practices instruction
• Review production batch records, logbooks, and associated documentation to assess completeness, accuracy, and compliance with SOPs.
• Inspect, review documentation, and release incoming raw materials and packaging components, as need.
• Update Quality SOP’S and perform secondary review of documentation.
• Perform area release for manufacturing, as needed.
• Perform Internal audits of GMP labs and other non-GMP
• Review of equipment and instrumentation documentation in support of GMP manufacturing and testing operations.
• Scanning manufacturing documentation such as batch records, raw materials, audits, investigations, CAPA, and change control.
• Release/disposition GMP products.
• Follow up on investigations, CAPAs and change controls for time completion.
• Review of documentation related to technology transfer from R&D for manufacturing activities.
• Other duties as assigned.

Specific skills

• Bachelor’s degree in life sciences
• 3-5 years sterile manufacturing experience.
• Previous experience in QA desirable.

• Have experience in writing SOPs and other associated GMP documentation
• Proficient in Microsoft Office, Excel, and Power Point
• Strong written and verbal communication skills.
• Strong organization skills.

Able to easily switch between multiple ongoing projects and adjust priorities based on business needs.

This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!