What are the responsibilities and job description for the Aseptic Manufacturing Technician **NEW as of 2/12/25 position at Quality Chemical Laboratories?
Job Summary: This position involves working in a controlled environment, adhering to Good Manufacturing Practices (GMP), and maintaining the highest quality standards. The technician will perform tasks related to the preparation, assembly, and sterilization of drug products, while ensuring the cleanliness, safety, and efficacy of aseptic drug products.
Key Responsibilities:
- Operate and monitor sterile manufacturing equipment used in the production of pharmaceuticals, including filling machines, autoclaves, and aseptic processing equipment.
- Follow Standard Operating Procedures (SOPs) and regulatory guidelines, ensuring all tasks are performed in compliance with GMP, FDA, and other relevant standards.
- Perform sterilization and filtration processes in a sterile environment.
- Maintain accurate documentation of production activities, including batch records, quality control checks, and equipment maintenance logs.
- Assist in the setup, cleaning, and sanitization of production areas and equipment, ensuring proper adherence to cleanliness protocols.
- Conduct routine inspections and maintenance of sterile equipment and systems, ensuring optimal functioning and preventing contamination risks.
- Collaborate with quality assurance and control teams to identify and resolve any production issues or discrepancies.
- Monitor and report on production metrics, such as yield, efficiency, and quality, to supervisors and managers.
- Adhere to health and safety protocols, ensuring a safe working environment at all times.
- Participate in training and development programs to stay current with industry best practices and regulatory requirements.
Qualifications:
- High School Diploma or equivalent and certificate in Bioprocess Technology (Associate degree or higher in a related field preferred).
- Previous experience in pharmaceutical or sterile manufacturing environments is highly desirable.
- Knowledge of GMP, FDA regulations, and sterile manufacturing practices.
- Familiarity with aseptic techniques and sterile environments.
- Strong attention to detail and a commitment to maintaining high-quality standards.
- Ability to troubleshoot and problem-solve issues related to equipment and production processes.
- Strong communication and teamwork skills.
- Ability to work in a fast-paced, regulated environment with a focus on precision and quality
- Willingness to work in shifts, including weekends and holidays, if necessary
Physical Requirements:
- Ability to lift up to 30 pounds.
- Ability to stand or sit for extended periods.
- Ability to work in a cleanroom environment with the use of personal protective equipment (PPE).
QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our 5-Star childcare facility.
