Manufacturing Associate

Indotronix Avani Group; Plainville (MA); On-site; USD 39,000 - 47,000; Full time

Benefits offered by this job

PPE provided

Job summary

Indotronix Avani Group is seeking for a manufacturing position based in Plainville, MA. The role involves following detailed work instructions, maintaining batch records, and supporting training staff in a cGMP environment.

The candidate should have at least one year of related experience, a high school diploma, and the ability to work in a fast-paced manufacturing setting while prioritizing safety and quality. PPE is provided and adherence to GMP rules is essential.

Qualifications

• High school diploma or equivalent required.
• Minimum of 1 year of work experience in manufacturing, operations, production, lab setting or related field.
• Preferred: Experience in a cGMP environment.

Responsibilities

• Execute work instructions and apply job skills to complete assignments.
• Achieve full training status and assist training staff.
• Maintain inventory records and accurate batch records.
• Inspect finished products for adherence to specifications.
• Adhere to Quality Management Systems and assist with Nonconformance/CAPA closures.
• Identify and communicate items requiring escalation.

Skills

GMP knowledge

Aseptic gowning

Documentation

Safety awareness

Equipment operation

Effective communication

Education

High school diploma

Job description

Shift: Week 1 – M, T, F, Sa and Week 2 – Su, W, Th

7.00 am to 7.00 pm - $28.00/hr w2

6:45 pm to 7:15 am - $34.50/hr w2

Summary:

• Execute work instructions and apply job skills to complete assignments.
• Achieve full training status and assist 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.

EDUCATION:

• High school diploma or equivalent required

Required:

• Minimum of 1 year of work experience in manufacturing, operations, production, lab setting or related field

Preferred:

Experience in a cGMP environment

PPE provided. No steel toes, but closed toed shoes, GMP environment regulations – no piercing, no polish

Required Skills:

• 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 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 write, read, and review documentation for extended periods.
• 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.
• Required to wear Personal Protective Equipment (PPE).
• Daily computer use.
• May work with dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, and experience marked changes in temperature.