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Role Summary
Packaging Technician I, MD Packaging B1 (6AM-6:30PM) — Manage production lines to meet the established production schedule in accordance with SOPs and GMPs while monitoring product to ensure quality standards are maintained. Shift: B1 6AM-6:30PM Thursday/Friday/Saturday and every other Wednesday.
Responsibilities
- 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 manual or automated assembly, filling, packaging and labeling of pharmaceutical products, ensuring adherence to specifications.
- Operate high-speed flow wrap equipment to support continuous workflow.
- Conduct serialization tasks, such as in-process inspections for production orders.
- 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 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 Changeovers on production lines in accordance with SOPs and cGMPs.
- Conduct in-process inspections and reconcile incoming and completed components and products to ensure accuracy.
- Examine finished product, document test results, and determine product acceptability based on specifications.
- Perform other duties as assigned.
Qualifications
- High School Diploma or equivalent with 1–2 years of manufacturing experience.
- Two years of related work experience, preferably in a high-speed production or manufacturing environment.
- Experience in a GMP regulated environment preferred.
- Basic knowledge of Microsoft Office; SAP experience preferred.
- Experience in an Aseptic Production environment preferred.
Essential Knowledge, Skills & Abilities
- Detail-oriented and self-motivated
- Excellent hand-eye coordination and manual dexterity
- Strong math skills (add, subtract, multiply, divide)
- Ability to read, comprehend, write, and communicate in English
- Ability to follow detailed written or oral instructions
- Professional teamwork and communication
- Ability to obtain and maintain Sr. Certified Operator Certification
- Proficiency with Windows-based systems; willingness to learn other systems
- Ability to work any shift (up to 12 hours) as required
- Ability to stand and walk continuously; wear gowning requirements
- Ability to lift up to 40 lbs; bend, climb, lift, squat, stoop, stretch
- Operate manual and automated production equipment effectively
Education
- High School Diploma or equivalent