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Quality & Compliance Manager

Job Duties & Responsibilities:
 Quality
• Build a quality management system in accordance with the FDA CGMP and ISO 9000:1 Standards
• Lead ISO 9000:1 accreditation process
• Create a quality manual
• Enforce quality system
• Investigate and create CAPA when quality issues arise
• Build and manage Quality Management portion of NetSuite
• Manage compliance and regulatory submissions pertaining to FDA, ISO and EPA
• Review each product and ensure correct quality control procedures are in place
• Perform quality tests on finished products
• Create procedures for quality testing during production where applicable
• Ensure quality records are up to date and in compliance
• Creation and/or management of SOP’s for every process
• Generation & Management of COC’s & COA’s
• Review and approve quality requirements for manufactured products, newly sourced raw materials & new products
• Develop, document and audit practices and quality manual
• Manage Quality system within NetSuite
• See quality issues through to completion and take final responsibility for resolution. This would include working with vendors and internal parties
 
Regulatory & Compliance – Manage site, product and labeling compliance
• Develop and oversee control systems to prevent or deal with violations of legal guidelines and internal policies
• Draft, modify and implement company policies
• Assess the business’s future ventures to identify possible compliance risks
• Review the work of colleagues when necessary to identify compliance issues and provide advice or training
• Prepare reports for senior management and external regulatory bodies as appropriate
• Keep abreast of regulatory developments within or outside of the company as well as evolving best practices in compliance control
• Manage compliance with governing bodies such as EPA, FDA, etc
• Including but not limited to reporting, monitoring raw material usage and allowances
• Manage SDS creation & compliance
• Ensure TDS are in compliance
• Prepare and review TDS & SDS
• Review Labels for compliance with applicable regulations
 
Requirements:
• High school diploma or equivalent
• Experience and some knowledge of the purchasing processes involved in manufacturing
• Detail and task oriented
• Willingness and ability to communicate
• Task and deadline oriented
• Adaptable to change
• Self motivated and self driven
• Able to see the big picture. Look long term with a “business owner” mindset
• Process driven and/or willing to follow set out process’s
• Comfortable with change and fast moving environment
• Focused on continuous improvement
• Able to deal with many moving parts
• Ambitious – want to create and build a career
• Open to constructive criticism and suggestions for improvement
• Team oriented
• Ability to learn and operate software (Salesforce CRM & Pardot Marketing Automation are utilized)
• Ability to identify what needs to be done and take action to complete it without it being explicitly directed or laid out in a job description or defined duties
• Not have to be micromanaged – but comfortable with having many eyes on your work. (small company plus an important role!)
• Ability to deal with high-pressure situations
• Ambitious!
• Not looking for a job that is low stakes, low pressure, and easily learned or easy to slot into.

Maintenance Tech & Engineer

Job Responsibilities
Preventative Maintenance
• Implement a PM program
• Research and contact vendor or manufacturer to identify recommended PM for all equipment
• Set up PM schedules for all equipment
• Identify critical wear parts and components for all equipment and ensure we have them on hand – continuously monitor
• Manage PM schedule and perform PMs on all equipment
 
Equipment Repairs:
o Manage equipment repairs as required
o Work to minimize downtime from down equipment
o Work with vendors, contractors, etc to source parts and or specialized labor as required for repairs
 
LOTO:
• Set up lock out tag out procedures for all equipment as required
• Monitor LOTO procedures and ensure they are being followed
• Set up master LOTO list and manage
 
Equipment Installation:
• Manage and facilitate installation and integration of new equipment from receiving to an initial production run
o Manage the coordination of internal and external parties to ensure installation timelines are met
o Help to identify optimal layouts and equipment placement
o Perform functions such as unloading & placing equipment, running and hooking up electricity, programming controls, programming VFD’s, and whatever is required to set up equipment
o Work directly with Vendors on equipment questions
 
Safety:
o Ensure all equipment is clearly marked with safety precautions
o Identify safety concerns and procedures for all equipment
o Monitor to ensure safety protocols are adhered to
 

Production Set Up:
o Set up equipment & machinery for production runs and perform start-up (lines and production cells should be ready for operators and production crew to just run production). Labelers, Fillers, Mixers, blow mold, extrusion machines, etc.
 
General Production:
o Fill in and help with general production tasks and jobs as required, or if all other projects are caught up and/or completed. This could include mixing, filling, assisting in warehouse & production lines
 
• Facilitate process set-up and start-up as needed
• Participate in daily production meetings and monthly safety meetings
•  Other duties as assigned
 
Requirements:
• High school diploma or equivalent
• Experience and some knowledge of the purchasing processes involved in manufacturing
• Detail and task-oriented
• Willingness and ability to communicate
• Task and deadline oriented
• Adaptable to change
• Self-motivated and self-driven
• Able to see the big picture. Look long-term with a “business owner” mindset
• Process driven and/or willing to follow set-out process’s
• Comfortable with change and fast-moving environment
• Focused on continuous improvement
• Able to deal with many moving parts
• Ambitious – want to create and build a career
• Open to constructive criticism and suggestions for improvement
• Team oriented
• Ability to identify what needs to be done and take action to complete it without it being explicitly directed or laid out in a job description or defined duties
• Not have to be micromanaged – but comfortable with having many eyes on your work. (small company plus an important role!)
• Ability to deal with high-pressure situations
• Ambitious!
• Not looking for a job that is low stakes, low pressure, and easily learned or easy to slot into.

Operations Manager

Final ownership & management of all production, warehouse, safety, maintenance & quality activities, operations, and personnel. 

Operations

  • Write and implement processes, checklists, and standards for all operational activities
  • Manage production/warehouse staff & schedules
  • Organize and allocate labor for the most efficient utilization
  • Help facilitate proof of function for new products
  • Identify and implement Improvements needed to make production more efficient, and increase output.
  • Manage Implementation and enforcement of CGMP
  • Bring Lean manufacturing practices to the table throughout the entire building.
  • Research ideas/project concepts, then take that information to make educated decisions for changes or fixes.
  • Help in making sure the company is efficient and organized from the onset of orders through shipping.
  • Manage facilities – including changes and improvements
  • Ensure warehouse and manufacturing areas are clean and tidy
  • Manage warehouse layout
  • Handle corrective actions from the start of the paperwork through the completion of the project.

Production

  • Manage Work Order Process
  • Manage the production floor & machinery.
  • Organize production schedules based on shipping needs.
  • Keep track of raw materials; making sure we do not run out of things needed for production.
  • Work in production when necessary
  • Make sure the BOMs are correct for our products, I.E. paperwork, work orders.
  • Question orders with missing info or lack of info to ensure customer satisfaction.

Safety

  • Implement, manage, and maintain a company safety program
  • Ensure OSHA compliance
  • Develop and document safety practices and policies; ensuring everyone is following policies.
  • Holding monthly company-wide safety meetings
  • Record safety incidents and issue warnings/citations for safety violations
  • Ensure correct PPE is on hand for all employees and being utilized.

PM

  • Develop, Implement, and monitor maintenance schedules & procedures
  • Keep machinery running and in good operational shape. Have things fixed or solutions for issues we are having and implement the corrective actions.

Quality

  • Implementation, enforcement, and maintenance of quality standards and procedures

New Equipment Installs:

  • Manage new equipment installs to meet timelines and run proof of function & concept runs

Requirements:

  • High school diploma or equivalent
  • Experience and some knowledge of the purchasing processes involved in manufacturing
  • Detail and task-oriented
  • Willingness and ability to communicate
  • Task and deadline oriented
  • Adaptable to change
  • Self-motivated and self-driven
  • Able to see the big picture. Look long-term with a “business owner” mindset
  • Process-driven and/or willing to follow set-out process’s
  • Comfortable with change and fast-moving environment
  • Focused on continuous improvement
  • Able to deal with many moving parts
  • Ambitious – want to create and build a career
  • Open to constructive criticism and suggestions for improvement
  • Team oriented
  • Ability to learn and operate software (NetSuite ERP is utilized)
  • Ability to identify what needs to be done and take action to complete it without it being explicitly directed or laid out in a job description or defined duties
  • Not have to be micromanaged – but be comfortable with having many eyes on your work. (small company plus an important role!)
  • Ability to deal with high-pressure situations
  • Ambitious!
  • Not looking for a job that is low stakes, low pressure, and easily learned or easy to slot into.

Production Worker

Job Duties & Responsibilities
• Complete work orders on time with all required and relevant information
• Report on defective products or machinery 
• Check stock levels and report deficiencies in products or raw materials 
• Keep the worksite clean & tidy and ensure the work area is clean at the end of the day
• Transfer raw materials to and from work station manually or with forklift trucks   
• Follow the company’s safety and quality guidelines
• Follow quality procedures and checks and keep an eye out for areas of quality improvement or defects
• Perform production tasks and operate production equipment including but not limited to:
• Mixing batches of product in mixing tanks
• Running fill line including filler, capper, labeler
• Box and package product
• Hand label boxes and/or product
• Palletize product
• Fill adhesive cartridges & sausages with equipment
• Repackage and/or restack product
• Assist with warehouse and/or shipping and receiving duties
• Assist in meeting operational goals in any way possible
 
Requirements:
• High school diploma or equivalent
• Experience and some knowledge of the purchasing processes involved in manufacturing
• Detail and task-oriented
• Willingness and ability to communicate
• Task and deadline oriented
• Adaptable to change
• Self-motivated and self-driven
• Able to see the big picture. Look long-term with a “business owner” mindset
• Process driven and/or willing to follow set-out processes
• Comfortable with change and fast-moving environment
• Focused on continuous improvement
• Able to deal with many moving parts
• Ambitious – want to create and build a career
• Open to constructive criticism and suggestions for improvement
• Team oriented
• Ability to identify what needs to be done and take action to complete it without it being explicitly directed or laid out in a job description or defined duties
• Not have to be micromanaged – but comfortable with having many eyes on your work. (small company plus an important role!)
• Ability to deal with high-pressure situations
• Ambitious!
• Not looking for a job that is low stakes, low pressure, and easily learned or easy to slot into.

Working Production Supervisor

Production Supervisor
This position is responsible for, but not limited to, coordinating daily production activities to maximize productivity and minimize cost while maintaining quality. This would be a working supervisory role.
Specialized Knowledge and Skills
Knowledge of raw materials, production process, quality control, and costs; Knowledge of hand tools and equipment is preferred. Knowledge of specific and general safety policies and procedures as relates to the plant and the position is preferred.
Job Duties & Responsibilities
• Help to manage daily work order flow and allocate labor appropriately
• Ensure work orders are completed in a timely manner with all the required information
• Help production staff set up workstations and ensure all raw materials and resources are set up to run production without stopping
• Monitor production and identify areas to improve both speed and efficiency
• Monitor and help ensure quality standards are maintained
• Ensuring compliance with safety and professional standards within a facility
• Assist with cross-training of personnel to perform all of the required job duties
• Assist in writing, implementing, and monitoring SOPs for every process performed
• Monitors operations for efficiency and safety. Ensure all regulatory requirements are met.
• Perform production duties as required by demand

Requirements:
• High school diploma or equivalent
• Experience and some knowledge of the purchasing processes involved in manufacturing
• Detail and task-oriented
• Willingness and ability to communicate
• Task and deadline oriented
• Adaptable to change
• Self-motivated and self-driven
• Able to see the big picture. Look long-term with a “business owner” mindset
• Process driven and/or willing to follow set-out process’s
• Comfortable with change and fast-moving environment
• Focused on continuous improvement
• Able to deal with many moving parts
• Ambitious – want to create and build a career
• Open to constructive criticism and suggestions for improvement
• Team oriented
• Ability to identify what needs to be done and take action to complete it without it being explicitly directed or laid out in a job description or defined duties
• Not have to be micromanaged – but comfortable with having many eyes on your work. (small company plus an important role!)
• Ability to deal with high-pressure situations
• Ambitious!
• Not looking for a job that is low stakes, low pressure, and easily learned or easy to slot into.

Lead Compounder

This role would be of lead compounder – taking responsibility and “owning” the mixing & compounding portion of the manufacturing process. Products that would be mixed would include cleaning products, adhesives & sealants. The person in this role would be responsible for the physical work that is required. When batches of product are not required, it would be expected that the person would fill in time with other production duties as directed by operations manager.
 
Job Duties & Responsibilities
• Lead batch mixes by following Batch Formula Sheets and Manufacturing Instructions and ensure all documentation is filled out and completed in a timely manner.
• Complete work orders as required with the required information and turn in to purchasing team
• Take final responsibility for quality and meeting timelines
• Transport raw materials to and from the warehouse as required
• Verifies raw chemical usage on each batch is added correctly with correct weights.
• Submit finished product samples to the lab for approval
• Transfer finished products into correct storage containers.
• Complete daily scale checks and calibrations of scales and other test equipment.
• Perform daily cleaning/sanitizing of equipment used in mixing including but not limited to all tanks, processing equipment, and chemical containers in accordance with current SOPs and cGMP.
• Adhere to safe work practices and maintain sanitary working conditions.
• Ensure the work area is clean, tidy, and free of safety hazards
• Perform and document all work activities in conformance with company standard operating procedures (SOPs) and cGMP requirements.
• Coordinate with the operations manager to prioritize workload based on manufacturing load and equipment start-up.
• General labor and production jobs as required
• Train co-workers on the compounding process
• Assist operations with setting up the correct compounding process and paperwork
• Assist operations in building adequate quality checks and ensure all quality checks and processes are carried out
• Assist operations in building and correcting SOPs for each step of the compounding process
 
Job Requirements:
• Working knowledge of chemical handling, blending, mixing, and related processes.
• Ability to operate Machines as needed, including kettles/tanks, mixers, pumps, filtration, and related process equipment.
• An understanding of equipment to be able to dissemble, clean, and reassemble as needed.
 
Requirements:
• High school diploma or equivalent
• Experience and some knowledge of the purchasing processes involved in manufacturing
• Detail and task-oriented
• Willingness and ability to communicate
• Task and deadline oriented
• Adaptable to change
• Self-motivated and self-driven
• Able to see the big picture. Look long-term with a “business owner” mindset
• Process driven and/or willing to follow set-out process’s
• Comfortable with change and fast-moving environment
• Focused on continuous improvement
• Able to deal with many moving parts
• Ambitious – want to create and build a career
• Open to constructive criticism and suggestions for improvement
• Team oriented
• Ability to learn and operate software (NetSuite ERP is utilized)
• Ability to identify what needs to be done and take action to complete it without it being explicitly directed or laid out in a job description or defined duties
• Not have to be micromanaged – but comfortable with having many eyes on your work. (small company plus an important role!)
• Ability to deal with high-pressure situations
• Ambitious!
• Not looking for a job that is low stakes, low pressure, and easily learned or easy to slot into.

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