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- Ability to work within an ISO 13485 and cGMP production environment and ensure compliance with our quality system.
- This role works in a multifaceted laboratory environment executing projects of low-high complexity and criticality with multi-functional teams.
- Execute documentation based on cGMP and cGDP procedures, as well as perform documentation review post manufacturing execution.
- Support pilot manufacturing of new project introductions and sustaining projects within cGMP workflows utilizing SOPs.
- Responsible for formulation of liquid components, filling of various liquids, and creating lyophilized product in an ISO cleanroom environment.
- Handling of liquid nitrogen according to OSHA safety guidelines and lifting of heavy liquid nitrogen Dewars using proper body mechanics.
- Visual inspection of lyophilized product and liquid product.
- Perform basic-intermediate arithmetic calculations as it pertains to total volume and liquid concentrations.
- Perform daily unit conversions as it pertains to gravimetric and volumetric measurements utilizing the metric system.
- Operate laboratory equipment such as pipettes, balances, centrifuges, pH meters and heat sealers.
- Responsible for Biodecontamination (cleaning, sanitization, etc.) and appearance of all formulation and lyophilization production areas.
- Author Non-Conformance Reports (NCR) and risk analysis memos.
- May perform other duties as assigned.
- Requires a bachelor's degree in a related field and at least 1 year of work experience or in similar/related industry; or high school diploma with 3 years' related work experience.
- 1 or more years' experience in Contract Manufacturing
- 3 or more years' experience in Formulations or Lab Bench
- 3 or more years' experience in pH/Balance/Pipette
- 5 or more years' experience in a GMP environment
- Must be punctual and maintain attendance.
- Excellent problem-solving skills and the ability to make critical decisions accordingly.
- Proven attention to detail
- Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
- Must be able to read, write, and converse in English to train and understand cGMP manufacturing and SOP's.
- Understands Manufacturing Production Processes as it pertains to product integrity processes.
- Knowledge of chemical and biological safety procedures.
- Knowledge of Formulation/Lyophilization operations and capabilities.
- Basic knowledge of microbiology and clean room workflows including aseptic technique
Manufacturing Technician - Carlsbad, United States - Marquee Staffing
Description
Position OverviewThe Manufacturing Technician II - Lyophilization is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. Under the general direction of the lead technician and the overall direction of the supervisor, this position shall be responsible for the hands-on execution of all activities in the production area. The Senior Laboratory Technician is expected to fully participate in both departmental projects and any quality working teams which may be applicable. existing procedures. All the specific requirements presented in this job description are applicable to the functional area in which it resides.
This role is 100% On-Site, Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 6:00 am - 7:30 am with a consistent schedule.
Duties and Responsibilities