Best Sanitizers

Employment Opportunities at Best Sanitizers

 

Regulatory Computer Validation Specialist

Walton, KY.

Job Summary:
Establish guidelines for computer system validation and oversee the computer and controls validation program to ensure compliance with FDA requirements. Responsible for establishing standardized and harmonized core quality systems and processes that are compliant, efficient, effective and employ best practices in industry. Focus will be on core computer systems, Management of Change, Validation, and Auditing. Ensure core quality systems and processes are properly implemented and maintained for sustained compliance. Ensure quality and regulatory compliance requirements are identified, documented, integrated, and maintained to avoid gaps and ineffectiveness. Performs all tasks in a safe manner observing cGMP and quality standards.

Duties:

  • Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes.
  • Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastructure projects.
  • Perform assessment of version/change control and new software rollouts.
  • Utilize knowledge of all phases of Software Project Development Life Cycle and broad contribution to Analysis, Design, Development, Testing and Deployment of Software Applications.
  • Ensure that the testing is sufficient to meet regulatory requirements (21 CFR Part 11, MDSAP).
  • Represent the quality and compliance department in area(s) of expertise, as and when necessary.
  • Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines and fulfill client and PPD requirements.
  • May perform vendor and internal audits and/or regulatory inspections.
  • Perform Data Integrity risk assessment of laboratory systems.
  • Prioritize risks and work with IT, QA, and Laboratory personnel to address Data Integrity gaps.
  • Evaluate proposed and existing instrument systems and laboratory applications for Data Integrity gaps.
  • Keeps informed of all existing and new regulatory requirements and ensures full compliance in the Company’s Quality Systems.

Qualifications:

  • Experience working in an FDA regulated industry is preferred.
  • Excellent organizational skills and attention to detail.
  • Must pass Homeland Security background check
  • Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, and current FDA/MHRA guidance on Data Integrity
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint)
  • Expertise in all aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis and Total Quality Management)
  • Knowledge of all GMP regulations including international regulations
  • Knowledge of applicable parts of 21 CFR regulations
  • May require knowledge of ISO standards where applicable
  • Ability to handle multiple and changing priorities and tight deadlines while remaining detail-oriented
  • Good verbal and written communication skills
  • Proactive approach to core competencies of the role
  • Ability to work independently with minimal supervision
  • 3+ years of experience working with Information Technology and a fundamental understanding of IT concepts
  • 3+ years of experience in a computer systems validation or quality assurance role
  • Or equivalent combination of education, training and experience that provides the knowledge, skills and abilities to perform the duties of the job.

Physical Requirements:

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move 10 pounds, and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

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.

To apply for this position, please send cover letter and resume to: srowe@bestsanitizers.com

 

Training Specialist

Walton, KY.

Job Summary:
An organized and experienced trainer to be responsible for evaluating the needs and current practices and creating and delivering a training development plan complete with materials, tutorials, instructions, and learning resources. The trainer will also be responsible for researching and selecting the best platform to deliver and utilize training materials. The training assessment helps trainers identify the mix of training techniques they will need to deliver. The trainer may focus on classroom training, using a combination of lectures, workshops and videos. If employees need to develop skills in using equipment, trainers may use demonstrations and one-to-one coaching sessions. The Trainer can make use of distance learning programs for employees who need to develop product knowledge or technical skills. Performs all tasks in a safe manner observing cGMP and quality standards.

Responsibilities:

  • Identify training needs by evaluating strengths and weaknesses
  • Translate requirements into trainings
  • Build training programs and prepare teaching plans
  • Direct structured learning experiences and monitor their quality results
  • Acclimate new hires to the business and conduct job training sessions
  • Deliver training courses
  • Assess training effectiveness to ensure incorporation of taught skills and techniques into employees work behavior
  • Stay abreast of the new trends and tools in employee development
  • Develop schedule to assess training needs
  • Communicate training needs and online resources
  • Create training strategies, initiatives, and materials
  • Test and review created materials
  • Instruct employee training and onboarding
  • Conduct training through new materials
  • Review employee performance and learning

Qualifications:

  • Experience working in an FDA regulated industry is preferred.
  • Excellent organizational skills and attention to detail.
  • Must pass Homeland Security background check
  • Proven experience in designing multiple training events in a corporate setting
  • Extensive knowledge of instructional design theory and learning principles
  • Proven ability to master the full training cycle
  • Familiarity with traditional and modern training methods, tools and techniques
  • Familiarity with talent management and succession planning
  • Bachelor’s degree in education, business, human resources, information technology, or related field
  • Certification from talent and training associations a plus
  • Two (2) years’ previous experience as a trainer, corporate training specialist, or related position
  • Proficient computer skills, Microsoft Office Suite (Word, PowerPoint, Outlook, and Excel), and instructional software
  • Experience with technologies and best practices for instructional manuals and teaching platforms
  • Strict adherence to company philosophy/mission statement/sales goals
  • Good interpersonal skills and communication with all levels of management
  • Able to multitask, prioritize, and manage time efficiently
  • Encouraging to team and staff; able to mentor and lead
  • Excellent verbal and written communication skills
  • Able to analyze problems and strategize for better solutions

Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move 10 pounds, and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

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.

To apply for this position, please send cover letter and resume to: srowe@bestsanitizers.com

 

Sanitation Technician

Walton, KY.

Job Summary:
The Sanitation Technician is responsible for cleaning and sanitizing production and blending equipment, the upkeep of manufacturing and production areas and the verification of weighing devices.

Duties:

  • Performs cleaning and sanitizing of equipment and machinery
  • Follows all BOP’s and BWI’s for cleaning and sanitizing of blending and filling equipment  
  • Completes daily, weekly, monthly and semi-annual cleaning checklists
  • Conducts fire extinguisher and eye wash station checks
  • Performs scale verifications weekly
  • Uses the proper protective equipment at all times
  • Trained on chemical handling and use
  • Has ability to be cross-trained to work in production and waste water when necessary
  • Operate sit down and stand up forklift
  • Operate scissor lift

Skills:

  • Must possess the ability to work well with others as well as independently
  • Strong time management skills
  • Thorough documentation and written communication skills
  • Works independently and follow through on assignments with minimal direction
  • Must be able to lift and/or move 50 lbs. on a regular basis
  • Must be able to stand or sit for long periods of time, have solid manual dexterity skills, and be able to reach, stoop, kneel, bend, push and pull repetitively.
  • Self-motivation in daily activities is a must

Requirements:

  • H. S. Diploma or GED equivalent required
  • One year of experience in manufacturing
  • One year of experience working with sanitation processes equipment preferred
  • Has the ability to interpret documents, regulations, operating instructions with accuracy
  • Experience in an FDA regulated and/or ISO certified environment preferred
  • Previous forklift experience and certification preferred
  • Must be able to work a flexible schedule, come in early or stay late when necessary

To apply for this position, please send cover letter and resume to: srowe@bestsanitizers.com