Aseptic Operator

Aseptic Operator ForDoz Pharma Corp. - 2.8 East Windsor, NJ Job Details Full-time $40,000 - $60,000 a year 4 days ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Flexible schedule Qualifications Environmental regulations EHS Interpersonal skills Pharmaceutical regulatory compliance Safety regulations Technical support High school diploma or GED Manufacturing standard operating procedures Manufacturing facility Attention to detail Production planning Pharmaceutical company experience Laboratory standard operating procedures Sterile products production Aseptic technique Safety standard operating procedures Standard operating procedures (SOPs) Environmental safety protocols Pharmaceutical manufacturing facility experience Full Job Description Job Brief ForDoz Pharma Corp., based in East Windsor, New Jersey, is a fully integrated pharmaceutical company specializing in the development and manufacturing of advanced sterile injectable drug products. Rooted in a commitment to quality excellence, ForDoz continues to expand the expertise and production capacity for both conventional and complex sterile drug formulations in the U.S Responsibilities Operate and monitor filling equipment utilizing HMI's, isolator technology, parts washer, autoclave, vial washers, depyrogenation tunnels etc…. Perform trending and monitoring of critical quality attributes, critical process parameters to maintain product quality. Offer technical support in root cause failure analysis for production, EHS, and Quality Incidents. Coordinate the equipment readiness within manufacturing. Participate in production planning and scheduling. Identify opportunities and effectively evaluate initiatives of process optimization, cost reduction, and quality improvement. Develop equipment and process standards, operating procedures, and training materials. Be on-call and respond to any after-hour event that impacts production. Actively participate in technology transfer. Support Pilot Test Runs, Validation Runs, Engineering Runs, and any other requirements as needed. Perform cleaning and sanitization of equipment and facility as necessary. Input into and review production log books as required. Maintain safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures; complying with legal regulations; monitoring environment. Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs. Documents production by completing forms, reports, logs, and records of equipment and batch records to a cGMP and GDP standard. Perform inspection, cleaning, and maintenance of the equipment in accordance with operational instructions. Strictly follow the internal SOPs and external regulations. Strictly following health and safety procedures and protocols. Quick and effective diagnosis and troubleshooting of routine or minor problems Complete other duties and tasks as assigned. Requirements High School Diploma plus 5+ years commercial pharmaceutical manufacturing experience. Demonstrate in-depth understanding of technical equipment used in pharmaceutical manufacturing. Flexible work hours and schedules. Attention to details and a strong focus on quality and safety. Thorough knowledge of machinery processes in an aseptic manufacturing environment. Thorough understanding of Standard Operating Procedures and current Good Manufacturing Practices. Knowledge of accepted practices and regulatory requirements associated with safety and protection of workers, environment, and site. Ability to work different shifts and overtime as required. Ability to work weekends and holidays as required. Be able to work efficiently and handle multiple task simultaneously. Ability to work in groups and be a team player. •Please note this position is not eligible for employment visa sponsorship now or in the future ForDoz Pharma Corp. is a specialty pharmaceutical company focusing on development, manufacturing, and commercialization of complex generic products (e.g. oncology and antifungal products) and improved existing products 505(b)(2). ForDoz Pharma Corp. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristics

Benefits:

401(k) Dental insurance Flexible schedule Health insurance Paid time off Vision insurance

Pay:

$40,000.00 - $60,000.00 per year

Education:

High school or equivalent (Required)

Experience:

GMP:

2 years (Required) Aseptic technique: 1 year (Required) Shift availability: Day Shift (Required) Ability to

Commute:

East Windsor, NJ 08520 (Required)

Work Location:

In person