Regulatory Document Control Specialist - (Health/Beauty/Med Device Manufacturing)
Job DescriptionRegulatory Document Control Specialist (Health/Beauty/Med Device Manufacturing)We are seeking an experienced Regulatory Document Control Specialist to join our team at PhytogenX, Inc.
in Morgantown, PA.
We are a Manufacturer of Health & Beauty products, as well as Medical Devices.
In this role, while reporting to the Regulatory Supervisor (R&D), you will maintain the Raw Material Regulatory Database and generate reports through Coptis and CMS.
Essential Duties:
Responsible for maintaining the raw material regulatory database Monitoring and prioritizing requests on Part Number Request Board Keeping Part Number Request Board up to date Creating new part numbers in Coptis and CMS Reviewing and updating existing part numbers Communicating with vendors to request documentation Ensuring raw materials meet regulatory standards Ensuring part numbers are correct and consistent across software's Notifying appropriate parties of changes to raw materials Coordinating with purchasing to approve raw material substitutions Coordinating with purchasing to obsolete discontinued part numbersGenerate reports from COPTIS:
Ingredients List:
Ingredients List (EU, US, Mixed, IL preliminary and final) Qualitative Ingredient Listing (Raw material INCI) Quantitative Ingredient Listing (QIL) Ingredient Listing with trade nameRaw materials reports:
SDS COA Compositional Breakdown of Raw Material Animal Testing Statements ISO Statements CMS report:
Finished Good GHS Compliant SDS Manufacturing Process Report Review for accuracy of new raw materials being added to COPTIS and CMS.
Review formulas for FREE FROM statements and update raw material documents in preparation for the declaration statement Other duties as assigned.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
Duties, responsibilities, and activities may change at any time with or without notice.
Physical Demands/Work Environment:
Physical Effort Ability to work a minimum of full-time hours and additional work hours/time based on company needs Ability to hear, see and speak adequately (with or without accommodations) to perform the essential functions of the role.
Hand/eye coordination is necessary to operate computer mouse, computer keyboard, stapler Occasionally required to stand; walk; use hands to touch; reach with arms; grasp with fingers Ability to lift and/or move objects up to 20 pounds Specific vision abilities required include close and peripheral vision, depth perception and the ability to adjust focus Work Environment is an Office/Lab Environment, R&D Dept.
within a Health & Beauty Manufacturing PlantOther Special Working Conditions:
Employees that become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case-by-case basis.
Experience and SkillsEducation Required:
High school diploma or equivalent is a minimum requirement An associate or bachelor's degree in chemistry or biology is preferredExperience Required:
0-2 years of experience in a production environment for pharmaceutical, biotechnology, cosmetic or skin care industry preferred.
Experience in data entry required.
Excellent computer, documentation, communication, and organizational skills.
Familiarity with personal care industry.
Good problem-solving skills.
Good time management.
Strong attention to detail.
Sound decision making.
Team player and self-motivated.
Ability to work in a cross-functional team environment.
Recommended Skills Attention To Detail Biology Biotechnology Communication Computer Keyboards Content Management Estimated Salary: $20 to $28 per hour based on qualifications.
in Morgantown, PA.
We are a Manufacturer of Health & Beauty products, as well as Medical Devices.
In this role, while reporting to the Regulatory Supervisor (R&D), you will maintain the Raw Material Regulatory Database and generate reports through Coptis and CMS.
Essential Duties:
Responsible for maintaining the raw material regulatory database Monitoring and prioritizing requests on Part Number Request Board Keeping Part Number Request Board up to date Creating new part numbers in Coptis and CMS Reviewing and updating existing part numbers Communicating with vendors to request documentation Ensuring raw materials meet regulatory standards Ensuring part numbers are correct and consistent across software's Notifying appropriate parties of changes to raw materials Coordinating with purchasing to approve raw material substitutions Coordinating with purchasing to obsolete discontinued part numbersGenerate reports from COPTIS:
Ingredients List:
Ingredients List (EU, US, Mixed, IL preliminary and final) Qualitative Ingredient Listing (Raw material INCI) Quantitative Ingredient Listing (QIL) Ingredient Listing with trade nameRaw materials reports:
SDS COA Compositional Breakdown of Raw Material Animal Testing Statements ISO Statements CMS report:
Finished Good GHS Compliant SDS Manufacturing Process Report Review for accuracy of new raw materials being added to COPTIS and CMS.
Review formulas for FREE FROM statements and update raw material documents in preparation for the declaration statement Other duties as assigned.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
Duties, responsibilities, and activities may change at any time with or without notice.
Physical Demands/Work Environment:
Physical Effort Ability to work a minimum of full-time hours and additional work hours/time based on company needs Ability to hear, see and speak adequately (with or without accommodations) to perform the essential functions of the role.
Hand/eye coordination is necessary to operate computer mouse, computer keyboard, stapler Occasionally required to stand; walk; use hands to touch; reach with arms; grasp with fingers Ability to lift and/or move objects up to 20 pounds Specific vision abilities required include close and peripheral vision, depth perception and the ability to adjust focus Work Environment is an Office/Lab Environment, R&D Dept.
within a Health & Beauty Manufacturing PlantOther Special Working Conditions:
Employees that become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case-by-case basis.
Experience and SkillsEducation Required:
High school diploma or equivalent is a minimum requirement An associate or bachelor's degree in chemistry or biology is preferredExperience Required:
0-2 years of experience in a production environment for pharmaceutical, biotechnology, cosmetic or skin care industry preferred.
Experience in data entry required.
Excellent computer, documentation, communication, and organizational skills.
Familiarity with personal care industry.
Good problem-solving skills.
Good time management.
Strong attention to detail.
Sound decision making.
Team player and self-motivated.
Ability to work in a cross-functional team environment.
Recommended Skills Attention To Detail Biology Biotechnology Communication Computer Keyboards Content Management Estimated Salary: $20 to $28 per hour based on qualifications.
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