Manufacturing Associate

Indotronix International Corporation•Plainville, MA

8d•Onsite

About The Position

The Manufacturing Associate will execute work instructions and apply job skills to complete assignments. This role involves achieving full training status and assisting in training staff. The associate will work on semi-routine assignments, receiving instruction on new processes. Key responsibilities include maintaining inventory and accurate batch records, inspecting finished products for adherence to specifications, and assisting with batch record reconciliation and preventative maintenance tasks. The associate must adhere to Quality Management Systems and assist with Nonconformance/CAPA closures, identify and communicate items requiring escalation, and maintain a clean and safe work environment. Following company policies including safety, training, GDP, and cleanroom gowning is essential. The role requires spending 90% of time in manufacturing suites.

Requirements

High school diploma or equivalent required
Minimum of 1 year of work experience in manufacturing, operations, production, lab setting or related field
Technical expertise in biopharmaceutical manufacturing equipment, principles, and processes.
Strong understanding of current GMP and safety standards.
Ability to function in a dynamic environment and balance multiple priorities.
Proficiency in learning new software and tools.
Ability to make decisions for moderately complex GMP manufacturing activities with minimal to moderate supervision.
Ability to recognize, understand, and respond to situations requiring further evaluation and report to senior operators or management.
Effective written and verbal communication skills with peers, senior associates, and area management.
Understanding of operational documents for GMP compliance, accuracy, and completeness.
Ability to safely perform activities to prevent releases, accidents, and injuries.
Ability to aseptically gown and/or sterile gown as needed.
Required to wear Personal Protective Equipment (PPE).
Specific vision requirements: close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
Regularly required to talk and hear; frequently required to sit and stand for extended periods.
Occasionally required to lift, walk, use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, or crouch.

Nice To Haves

Experience in a cGMP environment

Responsibilities

Execute work instructions and apply job skills to complete assignments.
Achieve full training status and assist in training staff.
Work on semi-routine assignments, receiving instruction on new processes.
Maintain inventory records and accurate batch records.
Inspect finished products for adherence to specifications.
Assist with batch record reconciliation and preventative maintenance tasks.
Adhere to Quality Management Systems and assist with Nonconformance/CAPA closures.
Identify and communicate items requiring escalation.
Maintain a clean and safe work environment.
Follow company policies including safety, training, GDP, and cleanroom gowning.
Spend 90% of time in manufacturing suites.
Write, read, and review documentation for extended periods.
Daily computer use.
May work with dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, and experience marked changes in temperature.