Operator 1 – 2nd Shift
Charter Medical Ltd.
- Follows Standard Operating Procedures (SOP) and Work Instructions (WI’s) to manufacture and package components of medical devices.
- Performs assembly, machine operation, label printing, and packaging as required. May be cross trained in multiple areas or focus in a primary area.
- Performs responsibility in accordance with production standards and rates while adhering to quality requirements.
- Conducts in-process inspection and testing of material to ensure it meets criteria, elevating to management and documenting/reporting defects into the production records.
- May require measuring and simple mathematical calculations to ensure product meets specification requirements.
- Labels and packages product as per internal specifications.
- Performs leak-testing and operates pouch sealing equipment according to product work instructions and company procedures.
- Maintains clean machinery, parts, and surrounding area.
- Completes all paperwork associated with daily tasks.
- Carries out job requirements and operates equipment within safety guidelines and reports any nonconformance.
- Adheres to GMP/QSR requirements and follows applicable QMS documentation (e.g., SOP’s, Work Instructions) to successfully accomplish job requirements.
- Follows Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required.
- Follows gowning procedures in designated areas.
- Follows established safety requirements and adheres to the Health Safety and Environment Management System.
- Performs other job-related responsibilities as assigned.
- Must be able to perform the essential functions of the job, with or without reasonable accommodations
- Ability to stand frequently
- Ability to sit often
- Ability walk and/or move around in a controlled environment occasionally
- Ability to use hands to grasp and perform fine manipulation frequently
- Ability to stretch/reach with hands and arms frequently
- Ability to lift arms overheard occasionally
- Ability to climb or balance occasionally
- Ability to stoop, kneel, crouch, or crawl occasionally
- Ability to talk or hear frequently
- Ability to lift up to 50lbs occasionally
- Ability to push and/or pull occasionally
- Ability to handle chemicals and/or lab work often
- High school graduate or equivalent.
- Ability to effectively communicate with coworkers and management. Business communication is conducted in English.
- Ability to comprehend and follow SOP’s, WI’s, policies, and procedures such a safety, quality, and HR that are written in English.
- Possess basic mathematical skills to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
- Basic understanding of Good Manufacturing Practices (GMP) and working within FDA regulated industries preferred.
- Basic computer skills including ability to use MS Outlook and automated manufacturing and quality systems.
- Excellent interpersonal skills with ability to get along well with others and work in a team environment.
- Ability to properly complete paperwork as required according to work instructions, standards, or other specifications.
- Excellent dependability and reliability
- Willingness to accept change, learn, and work with new processes
- Familiarity with an ERP system and Quality Management System (eQMS) preferred
- Must be able to work extended hours when required
- Machine Operation: Operate and supervise one or a group of machines for the manufacture, processing or packaging of products.
- Manual Dexterity: Perform manual movements and activities associated with occupied positions.
- Attention to Detail: Taking responsibility for a thorough and detailed method of working.
- Work Ethics and Values: Demonstrating and supporting the organization's ethics and values.
- Achievement Orientation: Being persistent and showing perseverance on achieving concrete and tangible results out of personal responsibility; getting optimum results from situations; being ready to take action and show tenacity in case of obstacles or resistance.