Assembler Associate II

Production Operator

The Production Operator is responsible for all tasks associated with production activities for aseptically filling and labeling the filled bottles/vials.

Requirement/Must Have:

• High school diploma or GED equivalent.
• Basic math skills (addition, subtracting, division and multiplication).
• Basic computer literacy (data entry, inventory software, Microsoft Office).
• Prior experience manufacturing in a GMP environment.
• Prior experience manufacturing in environment adhering to ISO standards.
• Ability to gown to work in a clean environment (Hood, shoe covers, coveralls, etc.).

Responsibilities:

• Follow established GMP instructions without deviation.
• Ability to execute highly complex or specialized work.
• Proactively monitor production activities (clearing of minor jams) and other types of downtime issues on the line to minimize impact to production process.
• Report any abnormal equipment function or product problems as soon as identified.
• Operate filling/labeling/other pieces of equipment according to established procedures or specifications.
• Operate multiple pieces of equipment at one time.
• Responsible for the accurate completion of the work order and other documentation.
• Safely operate all equipment and promptly report all incidents, injuries or safety hazards.
• Maintain accurate and legible records.
• Complete inspection of products and materials to ensure acceptable visual and physical appearance.
• Perform basic calculations.
• Maintain and replenish production materials.
• Complete general housekeeping tasks.
• Be a positive contributor to the production team.
• Take accountability for their as well as the team's performance and efficiency.
• Follow basic instructions with minimal instruction.
• Be able to communicate effectively: face to face, via phone, and email.
• Utilize computer-based programs: Microsoft Office, SAP, and other custom programs unique to production activities.

Nice to Have:

• 1+ years of experience in a medical device, pharmaceutical, or applicable filling operation.
• Previous knowledge of SAP.
• Clean room experience.