Assembly & Packaging Packer

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.

• Comply with all safety regulations and conduct all activities in a safe, efficient manner.
• Operate high-speed equipment for the manual or automated assembly, filling, packaging and labeling of pharmaceutical products: ensuring adherence to specifications.
• 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 document 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.
• 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.

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: High School degree or equivalent with one year of manufacturing experience.

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

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

Experience working in an Aseptic Production environment preferred.

Ability to read, comprehend, write, and communicate effectively in English.

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.

for men and 35 lbs. for women.

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.

Packaging Department:

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. 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. Helps keep waste and rejects to a minimum, recycling when possible. Ensures others entering the area also adhere to proper procedures, training, or assisting as needed. Notify supervisor and/or shift coordinator of equipment and quality issues.

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. Verify skid tags for correct product number, dating, and quality. 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. May be required to provide development and training to less experienced team members. Be willing to be flexible in achievement of team and department goals.

Entry level

Contract

Manufacturing

Staffing and Recruiting, Pharmaceutical Manufacturing, and Biotechnology Research