Controls Filling Operator I - First Shift

Nova Biomedical; Waltham (MA); On-site; USD 35,000 - 55,000; Full time

Job summary

An established industry player is seeking a Controls Filling Operator to join their team in Waltham, MA. This role involves the filling, sealing, labeling, and packaging of ampules and vials, ensuring compliance with quality standards and regulations. The ideal candidate will have a high school diploma and basic mechanical aptitude, along with a willingness to learn and adapt. This is a fantastic opportunity to work in a dynamic environment where your contributions will directly impact the quality of healthcare products. Join a dedicated team focused on excellence and innovation in the biomedical sector!

Qualifications

• Ability to follow written/verbal instructions and perform basic math.
• Entry-level knowledge of Quality System Regulations and OSHA standards.

Responsibilities

• Set up and operate controls filling equipment according to procedures.
• Document filling and packaging procedures accurately and completely.

Skills

Hand tools operation

Basic math and counting

Mechanical aptitude

Basic computer skills

Teamwork

Adaptability

Education

High School Diploma

Experience in GMP environment

Experience in automated filling operation

Tools

Filling equipment

Manual pallet jacks

Job description

Nova Biomedical is hiring a Controls Filling Operator in our Waltham, MA facility on the First Shift (6:45 AM - 3:15 PM). The Controls Filling Operator will be responsible for performing filling, sealing, labeling, and packaging of various ampule and vial controls by means of written and/or verbal instruction. They will also be responsible for recording all pertinent information as required in various assembly procedures and logs.

Other Responsibilities and Accountabilities Include:

• Set up per procedure and equipment specification for controls filling operation.
• Operating and monitoring of controls filling equipment - load/unload product, assure product is properly filled, sealed, labeled, and quarantined as required.
• Documentation - accurate and complete record of control filling and packaging procedure. Perform in-process testing and tonometry during filling process.
• Maintenance of Controls filling area and equipment including daily cleaning, cleaning between batches, periodic maintenance/calibration work orders.

Qualifications:

• Read and write English and follow written/verbal instructions.
• Performs basic math and counting.
• Basic mechanical aptitude.
• Entry-level knowledge of Quality System Regulations (QSR).
• Entry-level knowledge of OSHA safety standards.
• Entry-level knowledge of Good Manufacturing Practice (GMP).
• Physical Demands:
  • Must be able to perform tasks that may involve for extended periods of time standing, sitting, pushing, pulling, lifting, bending, kneeling, reaching, twisting, turning, climbing steps and carrying up to 40 pounds several times/hours a day.
  • Require repetitive use of arms/wrist/hands while setting up/working with equipment/computer throughout the day.
  • Will require use of Personal Protective Equipment (PPE) and may include, but not limited to, safety glasses, safety shoes, lab coat, bouffant, gloves, hearing protection, face shield, nuisance mask.
  • Must have good hand/eye coordination and visual acuity.
  • Must be able to distinguish color.

Skills and Competencies:

• Ability to work with hand tools and gauges to operate filling/packaging equipment such as vial fill/plug/cap system/shrink bander, ampule filler/labeler/auto traying system, syringe filler/labeler and sterilizers/autoclave.
• Willingness to learn, ability to adapt to change, and a positive attitude.
• Ability to operate manual pallet jacks.
• Must be able to work as part of a team or individually.
• Basic computer skills.

Education/Experience:

• High School Diploma or equivalent.
• Related experience in an automated vial/bottle and ampule filling operation is desired.
• Related experience in a Good Manufacturing Practice (GMP) environment is desired.