USA-Manufacturing Technician I (Manufacturing/Quality) 1st Shift

HireTalent; Pearl River (NY); On-site; USD 45,000 - 60,000; Full time

Job summary

A leading company in Pearl River is seeking a responsible individual for sampling and preparation tasks in a cGMP environment. The role involves executing SOPs, performing aseptic sampling, and maintaining compliance records. Ideal candidates will have a high school degree and relevant experience in a manufacturing setting.

Qualifications

• At least two years of experience in a cGMP manufacturing environment.
• Aseptic technique sampling experience preferred.

Responsibilities

• Execute SOPs in sampling processes in cGMP manufacturing.
• Prepare material for manufacturing processes.
• Maintain records in accordance with cGMP.

Skills

Aseptic technique

Communication

Regulatory compliance

Education

High School degree

Job description

This position is responsible for ensuring all sampling are collected within the required frequency. Sampling includes environmental monitoring and utilities sampling in cGMP areas. The position is also responsible for preparing all the material needed for the manufacturing process. Preparation includes Glassware washing, Transfer Assembly preparation and Autoclaving.
Responsibilities:
• Execute standard operating procedures (SOPs) in routine/non-routine sampling process in areas of the cGMP manufacturing facility.
• Perform aseptic sampling (Environmental monitoring sampling, WFI (water injection), PUW (Purified Water) and Clean Steam Sampling)
• Prepare material for manufacturing process (Glassware washing, Transfer Assembly preparation and, Autoclaving)
• Perform routine cleaning of the cGMP facility.
• Interact with other departmental personnel to assist in resolving manufacturing quality issues.
• Maintain records and documentation in accordance with a cGMP environment
• Work a flexible work schedule, weekends and holidays as required.
• Follows instructions on notification of deviations as they occur and provides information during investigations.
• Must be able to support additional manufacturing activities as needed.

Requisite Education/Skills:
• Education: High School degree with at least two years of experience or training in a cGMP manufacturing environment
• Aseptic technique sampling experience in GMP environment is preferred
• Strong content knowledge in cGMP/regulatory compliance.
• English fluent, both written and spoken
• Good communication and social skills