LanceSoft, Inc. ยท 2 months ago
Packaging Operator III
Confidential company is seeking a Packaging Operator III to manage production lines and ensure compliance with regulatory standards. The role involves operating high-speed equipment, completing documentation, and maintaining quality and safety standards in a pharmaceutical manufacturing environment.
Information Technology
Responsibilities
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
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
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
Qualification
Required
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
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
Preferred
Experience working in a GMP regulated environment preferred
SAP experience preferred
Experience working in an Aseptic Production environment preferred
Company
LanceSoft, Inc.
Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele.
H1B Sponsorship
LanceSoft, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (55)
2024 (32)
2023 (23)
2022 (25)
2021 (60)
2020 (80)
Funding
Current Stage
Late StageCompany data provided by crunchbase