Packaging Operator III

Job Summary:
• Manage production lines to meet the established production schedule in accordance with Standard Operating Procedures (SOPs) and Good Manufacturing Principles (GMPs) while monitoring product to ensure quality standards are maintained.

Job Details:
• Comply with all safety regulations and conduct all activities in a safe, efficient manner.
• Apply 5S and cGMPs in all areas of responsibility.
• Operate high-speed equipment for the manual or automated assembly, filling, packaging and labeling of pharmaceutical products: ensuring adherence to specifications.
• Perform tasks that may be verified by an independent individual; or perform inspection/verifications of work performed by others.
• Clean packaging rooms and machinery in accordance with SOPs and cGMPs.
• Conduct Set-Ups, in-process actions, data entry, and other computer-related tasks.
• Complete batch records accurately and documents production volumes in accordance with SOPs and cGMPs.
• Accept or reject products according to acceptability standards determined by cGMPs, customer requirements, and SOPs.
• Complete Line Clearances and Change-Overs on production lines in accordance with SOPs and cGMPs.
• Conduct in-process inspections and reconcile incoming and completed components and products to ensure accuracy and accountability.
• Perform other duties as assigned.
• Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.

Regulated Responsibilities (including cGMP and EHS):
• Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.
• Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate. The incumbent must be willing to take temporary assignments as required.

Education and Experience:
Minimum requirements for this position are:
Education: High School degree or equivalent with one year of manufacturing experience.

Technical experience: One (1) year related work experience, preferably in a high-speed production or manufacturing environment.

Regulatory experience: Experience working in a GMP regulated environment preferred.

Systems experience: Basic user knowledge of Microsoft Office, SAP experience preferred.

Aseptic experience: Experience working in an Aseptic Production environment preferred.

Essential Knowledge, Skills & Abilities:
• Detail-oriented and self-motivated
• Excellent hand-eye coordination and manual dexterity.
• Excellent math skills; ability to add, subtract, multiply, and divide.
• Ability to read, comprehend, write, and communicate effectively in English.
• Ability to carry out detailed written or oral instructions.
• Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
• Basic user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems.
• Ability to work any shift (up to 12-hours) as required dependent on business needs.
• Physically able to continuously stand and walk.
• Ability to work in a controlled environment and comply with gowning requirements such as: hairnets, beard covers, safety shoes, googles and/or safety glasses.
• Ability to interpret work instructions and standards of work independently.
• Physically able to lift up to 40 lbs. for men and 35 lbs. for women.
• Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently.
• Effective and efficient operation of manual and automated production equipment.
• Ability to use, clean, and store tools and other devices required for the performance of the job in a manner which prevents damage to the tools and / or equipment.

Principal Accountabilities:
Percent indicated is the average time spent on a task and will vary depending on the workflow.

Packaging Department:
1. 50% of the time: Responsible for assisting with the packaging of product in packaging areas using manual, high-speed, or advanced packaging equipment, monitoring product, making minor adjustments, and maximizing efforts to meet production goals without compromising quality. Perform set/up and changeovers on equipment, as required, in a timely accurate manner. Works on assigned lines and performs tasks as required. Ensures that equipment is operating in a safe and efficient manner. Monitors and maintains quality of the product in order to ensure that quality standards are met, and a minimum of in-process loss is incurred. May be required to ensure materials are on-hand and at designated lines. Coordinate with Maintenance, as needed, to resolve mechanical and quality issues in an effective and timely manner. Removes all trash and rejects and disposes of them properly, as appropriate. Helps keep waste and rejects to a minimum, recycling when possible. Inspects area daily for cGMP compliance and good housekeeping. Follows all department SOPs and procedures to ensure that low bioburden levels are maintained. Ensures others entering the area also adhere to proper procedures, training, or assisting as needed. Inspects area daily for cGMP compliance and good housekeeping. Notify supervisor and/or shift coordinator of equipment and quality issues.
2. 30% of the time: Complete all required documentation in an accurate, legible, and timely manner, with strict adherence to SOPs, cGMPs, and ISO guidelines. Documentation includes, but is not limited to, batch records and log books. Verify and document use of correct components. Ensure product is produced per the ECR/ECO batch record specifications, including packaging specifications, lot number identification, dating, and format. Record and/or verify finished pallets on pallet sheets. Verify skid tags for correct product number, dating, and quality. Work with Supervisor / Coordinator to revise / update SOPs as needed to facilitate accuracy and ease of completion.
3. 20 % of the time: Functions as a contributing team member through attendance at team meetings, supervisor meetings, and department training sessions, or other informational meetings as required. Actively provides input and suggestions to help analyze and resolve production problems. Continuously looks for ways to improve work processes. May be required to provide development and training to less experienced team members. Listen and be responsive to team members needs. Be willing to be flexible in achievement of team and department goals.

The max pay rate is 20/hr for this position