BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a GMP Filling Technician to work for a leading San Diego biotechnology company.
GMP Filling Technician
Responsible for completing/ensuring the completion of the manufacturing of final product in an FDA regulated environment. The Technician must perform manufacturing procedures and aseptic filling of final product in accordance with cGMP's (current Good Manufacturing Practices) and other applicable regulatory requirements.
Essential Duties and Responsibilities
Maintain production areas to cGMP compliance and inspection readiness.
Responsible for cleaning and sterilizing materials and vessels, preparing buffers and solutions, and operating processing equipment.
Follow production procedures, record process operations and data entries on batch records, carefully review all documentation, and check all calculations (e.g. batch records, labels, equipment readings).
Monitor all processing parameters during final product manufacturing for quality and compliance.
Participate and support implementation of changes in processes and policies to maintain high professional standards.
Skills, Knowledge & Abilities
Ability to work effectively under aseptic conditions for extended periods of time.
Display a strong focus on safety, quality, detail, and results.
Solid working knowledge of cGMP facility, equipment and/or aseptic filling operations.
Mechanical aptitude, basic problem solving skills, and a familiarity with computer-based systems.
Good written and communication skills.
Meticulous and detailed oriented.
Ability to adhere to written instructions (i.e. follow the rules and guidelines of the department) and to follow verbal instructions.
Ability to work weekends, off-shifts, and overtime as required.
Education and/or Experience
Associateâ€™s Degree in a scientific discipline preferred.
Minimum of 6 months to 2 years Biotech/Pharmaceutical experience.
Prior experience with aseptic processing, collagen manufacturing, and FDA interactions is highly desirable.
Experience with assembly, sanitization, and clean room practices is a must.
Experience in an aseptic cleanroom class 100 environment recommended