Job detailsJob Title: Aseptic Processing TechnicianEmployment Type: Permanent Position/HourlyCompensation: Competitive, based on experience. Includes medical/dental benefits, holiday and paid time off after successfully completing the introductory period, and 401k.Job Summary:We are seeking a dedicated and skilled Aseptic Processing Technician to join our team. This role requires an individual capable of working within a cGMP (current Good Manufacturing Practices) environment. The successful candidate will demonstrate strong attention to detail, a commitment to patient safety, and the ability to work in a fast-paced, regulated environment.Key Responsibilities:
- Adhere to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Participate in aseptic production processes, including component preparation, set-up, and aseptic processing, while maintaining cGMP documentation (e.g., batch records).
- Ensure daily operations run efficiently to meet production targets while maintaining product quality and safety for patient care.
- Contribute to the development and revision of Standard Operating Procedures (SOPs) and cGMP processes.
- Maintain logbooks for controlled areas, autoclaves, and other essential equipment.
- Troubleshoot critical manufacturing processes, ensuring effective communication and accurate documentation (batch records, logbooks, etc.).
- Perform routine cleaning and maintenance of environmentally controlled areas.
- Operate and calibrate equipment such as pH meters, balances, peristaltic pumps, and more, documenting all activities in the appropriate logbooks.
- Manage and document inventory of materials following cGMP standards.
Qualifications:
- Associates/bachelor's degree in science, Health, Engineering, Pharmacy or related field.
- Experience in cleanroom environments and working with aseptic techniques is preferred.
- Knowledge of cGMP operations is highly desirable.
- Must be capable of wearing all required personal protective equipment (PPE) such as gowns, hair bonnets, masks, gloves, goggles, and beard covers, maintaining high standards of personal hygiene (makeup, jewelry, and cosmetics are prohibited in production areas).
- Ability to perform aseptic gowning and related procedures in accordance with safety protocols.
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