1. High school diploma or equivalent (Required).
2. Prior experience or knowledge of packaging, labeling, quarantine receiving inspections, label review/control, and raw material sampling (Highly Preferred).
3. Previous GDPS, cGMP, GLP, Aseptic sampling (Highly Preferred).
4. Proficient in Microsoft Office Suites (e.g.: Excel & Outlook) - Required.
5. Prior experience using SAP software (Highly Preferred).
6. IVMS experience (Highly Preferred).
7. Previous experience working in a food, pharmaceutical, or medical device industry (Highly Preferred).
8. Ability to work a Monday through Friday, 6:30 AM to 8:00 AM schedule with occasional overtime as needed (Required).
9. Ability to lift up to 60 pounds (Required).
10. One (1) year of experience in a manufacturing environment (Highly Preferred).
11. Knowledge of 21CFR 111, 112, and 212 (Highly Preferred).
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Assisting in data entry in QMS system.
- May act as a liaison among warehouse, logistics, analytical and procurement department.
- Receiving, managing and tracking raw materials received from warehouse team.
- Scanning, imaging, organizing and maintaining documents related to raw material COA, SDS, test data collected from the laboratory.
- Archiving inactive records in accordance with the records retention schedule.
- Provide samples to RM Specialist, who will add the raw material information to the internal site and distribute testing task associated each material.
- Manage the auditing and inspection of label printing and distribution activities ensuring compliance with approved specifications, cGMP and SOP's.
- Review all incoming labels against the artwork provided.
- Sample and inspect all packaging materials that are received, and also review COC/COA/21CFR/Spec for all materials.
- Inspecting labels for quality to the customer's expectations.
- Preparing (rerolling) labels per the customers' specifications.
- Verifying job information and label accuracy.
- Machine Operator/basic computer data entry.
- Transport finished labels into shipping.
- Communicate quality issues to press person and/or supervisor.
- Update database for all materials.
- Create PM Spec for all materials.
- Control all retain samples of packaging and label materials.
- Initiate and investigate planned and unplanned deviations, non-conformances, and CRF as required.
MINIMUM KNOWLEDGE, SKILLS, & ABILITY REQUIREMENTS:
- Multitasking in a high volume driven, fast pace environment to meet shipping deadlines.
- Basic computer skillsdata entry, basic excel.
- Previous experience working in a food, nutritional supplement, drug related manufacturing environment preferred.
- Working knowledge of Microsoft Office products required.
- Must possess strong organizational and communication skills.
- Detail-oriented, ability to multi-task and prioritize tasks with strict deadlines.
- Able to use logic and reasoning to identify solutions to problems.
- Takes initiative and seeks additional training or direction as needed.
- Must be willing to abide by Cosmax NBT USA's policies and procedures, including those that are safety-related.
- Strong skills in basic math.
- Available to work rotating shifts (days, afternoons, nights) and weekends.
- Develop, write, review, and update departmental and other company SOPs.
- Perform duties of QC Inspector as needed. Must be able to inspect material/operation.
- Receive, inspect, and verify Purchase Order quantities for all outbound perishable loads.
- Allocation and returns of labels to be utilized in production.
- Initiate and follow up on holds and rejected materials, complete DMR (Damage Material Report) as needed. To be tracked in MRB (material review board).
- Help in any area as deemed by the Quality Manager.
- Perform other duties as assigned.
EDUCATION and/or EXPERIENCE:
- High school diploma or equivalent (Required).
- A minimum of one (1) year of experience in a manufacturing environment, particularly packaging (Preferred).
- Basic mechanical aptitude and good troubleshooting skills.
- Must be able to work well under pressure and work with production staff to do the same.
- Must have a proactive and continual improvement mindset.
- Previous experience working in a food, nutritional supplement, drug related manufacturing environment preferred.
- Must be willing to abide by Cosmax NBT USA's policies and procedures, including those that are safety related.
- Demonstrates a professional, team first attitude toward work and co-workers.
- Must be proficient in reading, writing, and speaking of English.
WORK ENVIRONMENT:
Manufacturing work environment. Constant physical activities are required for this position. Able to tolerate working environment with inside hot and cold temperatures.
PHYSICAL DEMANDS:
Activities include ability to reach overhead, squat, and bend at the waist; the ability to lift up to 50 pounds or more; ability to climb up and down stairs throughout a shift; tolerance of standing posture continuously during shift; intense walking is involved. Dexterity for manipulating work materials; repetitive motion; proficiency in reading, writing and speaking English. Ability to respond to safety signals, such as those generated by forklifts.
TRAVEL:
None
Cosmax NBT USA is committed to employing a diverse workforce. Qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, sexual orientation, protected veteran status, or disability.
Equal Opportunity Employer M/F/Disability/Veteran