GMP Manufacturing Tech

• Location: Dallas
• Type: Contract To Hire
• Job #38006

GMP Manufacturing Technician 
Our client is searching for an energetic and highly motivated professional to perform small-scale operations for manufacturing radiopharmaceutical clinical doses following current Good Manufacturing Practices (cGMP). This position requires great attention to detail, effective time management, willingness to work in a team environment and interest in optimization of processes. The GMP technician will be responsible for adhering to Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) for pharmaceuticals, gowning requirements, and all safety requirements involving handling of radioactive materials

Job Responsibilities include: 
–    Execute radioactive and non-radioactive manufacturing activities using proper aseptic technique according to written procedures
–    Perform radioactive isotope elution and chelation within a shielded isolator as part of GMP manufacturing
–    Maintain paper and electronic batch records, equipment logs, and other production records as directed per company procedures
–    Work concurrently with Quality Assurance and Quality Control personnel to deliver a quality product
–    Follow and adhere to production schedules and timelines, and adjusting to shifting timelines as necessary
–    Execute room and equipment preparation for manufacturing operations
–    Maintain stock of manufacturing raw materials and obtain necessary documentation for material release by QA
–    Identify, document, and communicate process failures during manufacturing
–    Identify common equipment/process failures and troubleshoot solutions for operational challenges
–    Assist in deviation investigations, corrective actions, and preventive actions
–    Clean, sanitize and sterilize equipment and components to support production operations
–    Perform room sanitization activities as needed to maintain controlled environment conditions

Qualifications: 
–    Must maintain flexible hours to accommodate variable/non-standard production schedule
–    2 years GMP operation experience preferred
–    Bachelor of Science degree or equivalent work experience
–    Understanding of aseptic technique, familiarity with cleanroom operations
–    Excellent documentation skills and attention to minute detail
–    Excellent communication, problem-solving and organizational skills
–    Ability to follow written and verbal instruction
–    Ability to work both under direct supervision and independently while maintaining the same quality of work
–    Computer literacy and experience with Microsoft Office
–    Ability to understand and execute basic mathematical calculations
–    Interest working in a very fast-paced, high-growth team environment
–    Previous experience with electronic batch records and quality management systems a plus
–    Previous experience working in classified areas a plus