POSITION SUMMARY:
The Manufacturing Technician I will be responsible for performing routine and complex tasks for the GMP manufacturing and packaging of pharmaceutical products. The successful candidate will be familiar with best practices for cGMP assembly and packaging of combination pharmaceutical products. This individual is responsible for the documentation and the hands-on execution of production activities related to assembly, final packaging, and inspection of manufactured pharmaceutical products.
This individual operates in accordance with policies and procedures, environmental, health, safety, and cGMP guidelines.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Responsible for quality and adheres to all manufacturing process and quality requirements according to the APMOF quality process.
• Receives and distributes supplies in the manufacturing area.
• Performs the assembly, final packaging, and inspection of pharmaceutical products.
• Assembles products following all current Standard Operating Procedures (SOPS) and Work Instructions (WIs), while meeting manufacturing goals and metrics.
• Ability to maintain accurate records following Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP) guidelines including training files and shop floor paperwork.
• Perform other related duties as assigned.
EDUCATIONAL REQUIREMENTS (degree, license, certification):
· High School Diploma or equivalent is required.
YEARS OF EXPERIENCE:
· Prior experience in a manufacturing environment preferred, preferably in the pharmaceutical or biotechnology industry.
OTHER SKILLS AND ABILITIES:
· Must be able to work in a controlled or clean room environment requiring special gowning.
· Critical understanding of the importance of documentation and data traceability.
· Must have the ability to work safely and responsibly in a manufacturing environment.
· Familiarity with executing Standard Operating Procedures (SOPs) in a manufacturing or assembling environment, preferably in the pharmaceutical industry.
· Demonstrates attention to detail.
· Working knowledge of Good Documentation and good Manufacturing Practices preferred.
· Must be able to work well independently and in a team environment.
· Excellent communication skills, both verbal and written.
· Excellent organizational skills
· Must have the ability to lift up to 50 pounds.
· Able to perform physical activity such as standing for long periods of time, walking, and working with hands.
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