- Create filling and assembly instructions for new products and update existing filling and assembly instructions
- Manage line trials for new products and provide technical input to ensure client specifications are achieved within the machine capabilities
- Collect line trial data and provide a technical summary of the results for internal and client use
- Host corporate clients and respond to inquiries regarding the Quality Management System and production processes
- Create shipping labels in accordance with client logistics specifications
- Create and update Standard Operating Procedures (SOPs) in the Quality Management System in accordance with ISO 9001, 22716 and FDA CFR Parts 210 and 211.
- Perform internal audits, track and trend audit findings, and issue non-conformances or CAPAs for repeat findings.
- Conduct complaint investigations or product studies to address quality concerns or determine the root cause and corrective actions
- Cross-functional coordination with all departments to respond to client requests
- Any additional directives as assigned by Quality management
- Bachelors degree in Chemistry or related field
Skills and Qualifications Required
- Ability to create and maintain documentation in accordance with all relevant regulatory requirements.
- Strong sense of urgency.
- Proactive and continual improvement mindset.
- Highly developed analytical skills and demonstrated track record of translating analysis to process solutions.
- Excellent verbal and written communications skills.
- Excellent detail orientation.
- Expertise with Microsoft Office Suite.
- Experience in Regulatory Affairs/FDA-regulated environment within the Food or similar industry.
- Knowledge/Experience with the following; The Food & Cosmetic Act (FD&C), The Fair Packaging and Labeling Act (FLPA), cGMPs, Federal/State regulations, as well as EU, Canada, and Asia Cosmetic regulations and compliance standards, and with the Globally Harmonized System of Classification and Labeling (GHS).
- Ability to lift 35 lbs
- Prolonged sitting
- Walking throughout plant regularly
- Dexterity for manipulating computers and source materials
- Proficiency in the reading, writing and speaking of the English language
- Work environment requires use of Personal Protective Equipment
- Ability to respond to safety signals, such as those generated by equipment
Due to the fact that the US market is free of a market dominator, it is possible to establish a competitive strategy. Many believe now is the perfect time to enter the US market.
With the opening of our Ohio factory, we realized an integrated management system ranging from R&D to production and marketing in the US, as we did in China and Indonesia.
Thanks to the popularity of K-Beauty and other Korean cosmetics companies American consumers are welcoming our products.
The superb technical capability and services of Cosmax will be instrumental in spreading your brand name among Americans.
Additionally products that will be manufactured with the full support of the R&I center in Korea will far surpass the value of competing products. In the future, Cosmax USA will grow while excelling in the fundamentals such as R&D and manufacturing in accordance with the demands of local market.