Job Summary of the Material Control Technician

The Material Control Technician will help support and execute process controls for human tissue, critical supplies, and support functions throughout the Axogen Processing Center cGMP facility for surgical transplantation while ensuring compliance with applicable federal, state and AATB/FDA regulations. The Material Control Technician will support the Supervisor, Lead Technician and Engineering team as required in the Manufacturing and Processing Operations.

Requirements of the Material Control Technician

• High School Diploma or equivalent
• Valid driver’s license
• Experience in a cGMP environment is preferred, not required
• Forklift Cetification is preferred, not required
• ERP system experience is preferred, not required
• Must be proficient and able to effectively assist in training of current processes.
• Experience in 1 or more additional cross-functional support skills required (e.g. environmental monitoring, inventory recording, etc.).
• Ability to make decisions based on awareness of area operations is necessary.
• Good written/verbal communication skills, interpersonal skills and analytical troubleshooting skills.
• Must be able to deal with people under high pressure and in a constantly changing environment.
• Must be able to travel to and work at other Axogen locations on an as needed basis.
• Requires exerting up to 50 pounds of force occasionally and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to lift, carry, push, pull or otherwise move objects.
• Requires the following physical abilities: mental acuity, visual acuity, walking and standing for longer period of time, repetitive motion, speaking, grasping, manual dexterity, talking, and hearing.

Responsibilities of the Material Control Technician

The specific duties of the Material Control Technician include but are not limited to:

• Receives, stores, picks and ships raw materials, supplies and/or finished products in conjunction with internal and external requirements.
• Handles, moves and stores various non-hazardous and hazardous materials.
• Coordinates timely accurate flow of materials from warehouse inventory to work-in-process/production areas.
• Coordinates timely accurate flow of finished products to support shipments to customers and other destinations.
• Responsible for implementing and maintaining the effectiveness of the quality system, including maintaining proper first in and first out.
• Store, issue, or prepare materials in the warehouse, verifying the lot number, quantity, release status and any other unique identifiers using good documentation practices.
• Check materials against packaging lists, invoices, freight bills or other pertinent documentation to assure conformity and accuracy.
• Deliver materials to processing areas in a timely manner, maintain proper FIFO flow of raw materials and other time sensitive supplies.
• Maintain and sustain organized workspaces for tissue, supplies, and finished goods warehouse areas.
• Maintain accurate records and reconcile inventory errors.
• Accountable for personal safety and adhering to the safety guidelines.
• Must supply materials to functional areas or move to and from dock areas to maintain efficient shipping and receiving operations.
• This position is accountable for complying with applicable FDA (GMP), USDA, OSHA and Axogen regulations, policies, procedures or guidelines, assembly and review, processing, debridement, cleaning, safety, cleanroom behavior and documentation as needed.
• Participate in daily stand-up meetings, continuous improvement projects, adhere to established work practices like Kanban signals, and 5S initiatives.
• Performs other duties as directed by Supervisor.
• May be required to work in other Axogen roles or departments as needed.
• Complies with all company policies, procedures and SOPs.
• Required to cover call schedule, to include, holidays and weekends as assigned.

Working & Environmental Conditions

• Subject to handle potential infectious human tissue, nerves, umbilical cords, blood and bodily fluids. Also, subject to handle chemicals and hazardous / non-hazardous waste. Work involves risks or discomforts which require proper standard and universal precautions in a Biomedical manufacturing environment e.g., use of safe workplace practices with manufacturing equipment, wearing PPE during various tasks/activities including but not limited to, gowns, gloves, masks and safety glasses. Potential exposure to latex from gloves.
• May be required to sit for 2-4 hours or more debriding and evaluating unprocessed and processed human tissue. Required to wear surgical magnification loupes for 2-4 hours or more to evaluate tissue unprocessed and processed tissue.

Location

913 Industrial Drive Place, Vandalia, OH  45377

Benefits/Compensation

Job Summary of the Material Control Technician

The Material Control Technician will help support and execute process controls for human tissue, critical supplies, and support functions throughout the Axogen Processing Center cGMP facility for surgical transplantation while ensuring compliance with applicable federal, state and AATB/FDA regulations. The Material Control Technician will support the Supervisor, Lead Technician and Engineering team as required in the Manufacturing and Processing Operations.

Requirements of the Material Control Technician

• High School Diploma or equivalent
• Valid driver’s license
• Experience in a cGMP environment is preferred, not required
• Forklift Cetification is preferred, not required
• ERP system experience is preferred, not required
• Must be proficient and able to effectively assist in training of current processes.
• Experience in 1 or more additional cross-functional support skills required (e.g. environmental monitoring, inventory recording, etc.).
• Ability to make decisions based on awareness of area operations is necessary.
• Good written/verbal communication skills, interpersonal skills and analytical troubleshooting skills.
• Must be able to deal with people under high pressure and in a constantly changing environment.
• Must be able to travel to and work at other Axogen locations on an as needed basis.
• Requires exerting up to 50 pounds of force occasionally and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to lift, carry, push, pull or otherwise move objects.
• Requires the following physical abilities: mental acuity, visual acuity, walking and standing for longer period of time, repetitive motion, speaking, grasping, manual dexterity, talking, and hearing.

Responsibilities of the Material Control Technician

The specific duties of the Material Control Technician include but are not limited to:

• Receives, stores, picks and ships raw materials, supplies and/or finished products in conjunction with internal and external requirements.
• Handles, moves and stores various non-hazardous and hazardous materials.
• Coordinates timely accurate flow of materials from warehouse inventory to work-in-process/production areas.
• Coordinates timely accurate flow of finished products to support shipments to customers and other destinations.
• Responsible for implementing and maintaining the effectiveness of the quality system, including maintaining proper first in and first out.
• Store, issue, or prepare materials in the warehouse, verifying the lot number, quantity, release status and any other unique identifiers using good documentation practices.
• Check materials against packaging lists, invoices, freight bills or other pertinent documentation to assure conformity and accuracy.
• Deliver materials to processing areas in a timely manner, maintain proper FIFO flow of raw materials and other time sensitive supplies.
• Maintain and sustain organized workspaces for tissue, supplies, and finished goods warehouse areas.
• Maintain accurate records and reconcile inventory errors.
• Accountable for personal safety and adhering to the safety guidelines.
• Must supply materials to functional areas or move to and from dock areas to maintain efficient shipping and receiving operations.
• This position is accountable for complying with applicable FDA (GMP), USDA, OSHA and Axogen regulations, policies, procedures or guidelines, assembly and review, processing, debridement, cleaning, safety, cleanroom behavior and documentation as needed.
• Participate in daily stand-up meetings, continuous improvement projects, adhere to established work practices like Kanban signals, and 5S initiatives.
• Performs other duties as directed by Supervisor.
• May be required to work in other Axogen roles or departments as needed.
• Complies with all company policies, procedures and SOPs.
• Required to cover call schedule, to include, holidays and weekends as assigned.

Working & Environmental Conditions

• Subject to handle potential infectious human tissue, nerves, umbilical cords, blood and bodily fluids. Also, subject to handle chemicals and hazardous / non-hazardous waste. Work involves risks or discomforts which require proper standard and universal precautions in a Biomedical manufacturing environment e.g., use of safe workplace practices with manufacturing equipment, wearing PPE during various tasks/activities including but not limited to, gowns, gloves, masks and safety glasses. Potential exposure to latex from gloves.
• May be required to sit for 2-4 hours or more debriding and evaluating unprocessed and processed human tissue. Required to wear surgical magnification loupes for 2-4 hours or more to evaluate tissue unprocessed and processed tissue.

Location

913 Industrial Drive Place, Vandalia, OH  45377

Benefits/Compensation

Job Summary of the Material Control Technician

The Material Control Technician will help support and execute process controls for human tissue, critical supplies, and support functions throughout the Axogen Processing Center cGMP facility for surgical transplantation while ensuring compliance with applicable federal, state and AATB/FDA regulations. The Material Control Technician will support the Supervisor, Lead Technician and Engineering team as required in the Manufacturing and Processing Operations.

Requirements of the Material Control Technician

• High School Diploma or equivalent
• Valid driver’s license
• Experience in a cGMP environment is preferred, not required
• Forklift Cetification is preferred, not required
• ERP system experience is preferred, not required
• Must be proficient and able to effectively assist in training of current processes.
• Experience in 1 or more additional cross-functional support skills required (e.g. environmental monitoring, inventory recording, etc.).
• Ability to make decisions based on awareness of area operations is necessary.
• Good written/verbal communication skills, interpersonal skills and analytical troubleshooting skills.
• Must be able to deal with people under high pressure and in a constantly changing environment.
• Must be able to travel to and work at other Axogen locations on an as needed basis.
• Requires exerting up to 50 pounds of force occasionally and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to lift, carry, push, pull or otherwise move objects.
• Requires the following physical abilities: mental acuity, visual acuity, walking and standing for longer period of time, repetitive motion, speaking, grasping, manual dexterity, talking, and hearing.

Responsibilities of the Material Control Technician

The specific duties of the Material Control Technician include but are not limited to:

• Receives, stores, picks and ships raw materials, supplies and/or finished products in conjunction with internal and external requirements.
• Handles, moves and stores various non-hazardous and hazardous materials.
• Coordinates timely accurate flow of materials from warehouse inventory to work-in-process/production areas.
• Coordinates timely accurate flow of finished products to support shipments to customers and other destinations.
• Responsible for implementing and maintaining the effectiveness of the quality system, including maintaining proper first in and first out.
• Store, issue, or prepare materials in the warehouse, verifying the lot number, quantity, release status and any other unique identifiers using good documentation practices.
• Check materials against packaging lists, invoices, freight bills or other pertinent documentation to assure conformity and accuracy.
• Deliver materials to processing areas in a timely manner, maintain proper FIFO flow of raw materials and other time sensitive supplies.
• Maintain and sustain organized workspaces for tissue, supplies, and finished goods warehouse areas.
• Maintain accurate records and reconcile inventory errors.
• Accountable for personal safety and adhering to the safety guidelines.
• Must supply materials to functional areas or move to and from dock areas to maintain efficient shipping and receiving operations.
• This position is accountable for complying with applicable FDA (GMP), USDA, OSHA and Axogen regulations, policies, procedures or guidelines, assembly and review, processing, debridement, cleaning, safety, cleanroom behavior and documentation as needed.
• Participate in daily stand-up meetings, continuous improvement projects, adhere to established work practices like Kanban signals, and 5S initiatives.
• Performs other duties as directed by Supervisor.
• May be required to work in other Axogen roles or departments as needed.
• Complies with all company policies, procedures and SOPs.
• Required to cover call schedule, to include, holidays and weekends as assigned.

Working & Environmental Conditions

• Subject to handle potential infectious human tissue, nerves, umbilical cords, blood and bodily fluids. Also, subject to handle chemicals and hazardous / non-hazardous waste. Work involves risks or discomforts which require proper standard and universal precautions in a Biomedical manufacturing environment e.g., use of safe workplace practices with manufacturing equipment, wearing PPE during various tasks/activities including but not limited to, gowns, gloves, masks and safety glasses. Potential exposure to latex from gloves.
• May be required to sit for 2-4 hours or more debriding and evaluating unprocessed and processed human tissue. Required to wear surgical magnification loupes for 2-4 hours or more to evaluate tissue unprocessed and processed tissue.

Location

913 Industrial Drive Place, Vandalia, OH  45377

Benefits/Compensation

Job Summary of the Processing Technician

The Processing Technician will perform debridement and processing, packaging and labeling of human tissue products for surgical transplantation while ensuring compliance with applicable federal, state and AATB regulations. 

Requirements of the Processing Technician

• High School Diploma or equivalent.
• Universal precautions and sterile technique (i.e. surgical technician, medical assistant, lab technician) preferred. 

Responsibilities of the Processing Technician

• The specific duties of the Processing Technician include but are not limited to:
• Performs processing, debridement, packaging, labeling and shipment of finished product.
• Participates in the receiving and inspection of incoming unprocessed tissue.
• Utilizes special techniques, instrumentation, and equipment to clean and size tissue to specifications and protocols.
• Assists team lead with efforts in maintaining inventory levels on the core and dock for receiving supplies.
• Performs lab cleaning activities as required by policies, protocols, procedures, and SOPs.
• Work with Quality and Regulatory staff to ensure compliance with all federal, state, and AATB regulations and requirements, particularly those pertaining to manufacturing.
• Complete documentation as required in processing in accordance with standard operating procedures and quality standards.
• Assists with production records as needed.
• Complies with all company policies, procedures, and SOPs.
• Performs all other duties assigned by the supervisor. 

Physical Requirements

The work is medium work which requires exerting up to 60 pounds of force occasionally and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to lift, carry, push, pull or otherwise move objects. Additionally, the work requires the following physical abilities: mental acuity, visual acuity, walking, repetitive motion, speaking, grasping, manual dexterity, talking, and hearing.

Working & Environmental Conditions

Work involves risks or discomforts which require proper safety precautions in a Biomedical manufacturing environment e.g., use of safe workplace practices with manufacturing equipment, wearing gloves for PPE during various tasks/activities including but not limited to, gloves, masks and safety glasses avoidance of trips and falls, and observance of fire and building safety regulations. Occasional potential exposure to hazards such as chemicals, blood or bodily fluids, communicable diseases, saw blades, needles, or other sharp objects, moving mechanical parts, and latex exposure. 

Location

913 Industrial Drive Place, Vandalia, OH  45377

Benefits/Compensation

Job Summary of the Material Control Technician

The Material Control Technician will help support and execute process controls for human tissue, critical supplies, and support functions throughout the Axogen Processing Center cGMP facility for surgical transplantation while ensuring compliance with applicable federal, state and AATB/FDA regulations. The Material Control Technician will support the Supervisor, Lead Technician and Engineering team as required in the Manufacturing and Processing Operations.

Requirements of the Material Control Technician

• High School Diploma or equivalent
• Valid driver’s license
• Experience in a cGMP environment is preferred, not required
• Forklift Cetification is preferred, not required
• ERP system experience is preferred, not required
• Must be proficient and able to effectively assist in training of current processes.
• Experience in 1 or more additional cross-functional support skills required (e.g. environmental monitoring, inventory recording, etc.).
• Ability to make decisions based on awareness of area operations is necessary.
• Good written/verbal communication skills, interpersonal skills and analytical troubleshooting skills.
• Must be able to deal with people under high pressure and in a constantly changing environment.
• Must be able to travel to and work at other Axogen locations on an as needed basis.
• Requires exerting up to 50 pounds of force occasionally and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to lift, carry, push, pull or otherwise move objects.
• Requires the following physical abilities: mental acuity, visual acuity, walking and standing for longer period of time, repetitive motion, speaking, grasping, manual dexterity, talking, and hearing.

Responsibilities of the Material Control Technician

The specific duties of the Material Control Technician include but are not limited to:

• Receives, stores, picks and ships raw materials, supplies and/or finished products in conjunction with internal and external requirements.
• Handles, moves and stores various non-hazardous and hazardous materials.
• Coordinates timely accurate flow of materials from warehouse inventory to work-in-process/production areas.
• Coordinates timely accurate flow of finished products to support shipments to customers and other destinations.
• Responsible for implementing and maintaining the effectiveness of the quality system, including maintaining proper first in and first out.
• Store, issue, or prepare materials in the warehouse, verifying the lot number, quantity, release status and any other unique identifiers using good documentation practices.
• Check materials against packaging lists, invoices, freight bills or other pertinent documentation to assure conformity and accuracy.
• Deliver materials to processing areas in a timely manner, maintain proper FIFO flow of raw materials and other time sensitive supplies.
• Maintain and sustain organized workspaces for tissue, supplies, and finished goods warehouse areas.
• Maintain accurate records and reconcile inventory errors.
• Accountable for personal safety and adhering to the safety guidelines.
• Must supply materials to functional areas or move to and from dock areas to maintain efficient shipping and receiving operations.
• This position is accountable for complying with applicable FDA (GMP), USDA, OSHA and Axogen regulations, policies, procedures or guidelines, assembly and review, processing, debridement, cleaning, safety, cleanroom behavior and documentation as needed.
• Participate in daily stand-up meetings, continuous improvement projects, adhere to established work practices like Kanban signals, and 5S initiatives.
• Performs other duties as directed by Supervisor.
• May be required to work in other Axogen roles or departments as needed.
• Complies with all company policies, procedures and SOPs.
• Required to cover call schedule, to include, holidays and weekends as assigned.

Working & Environmental Conditions

• Subject to handle potential infectious human tissue, nerves, umbilical cords, blood and bodily fluids. Also, subject to handle chemicals and hazardous / non-hazardous waste. Work involves risks or discomforts which require proper standard and universal precautions in a Biomedical manufacturing environment e.g., use of safe workplace practices with manufacturing equipment, wearing PPE during various tasks/activities including but not limited to, gowns, gloves, masks and safety glasses. Potential exposure to latex from gloves.
• May be required to sit for 2-4 hours or more debriding and evaluating unprocessed and processed human tissue. Required to wear surgical magnification loupes for 2-4 hours or more to evaluate tissue unprocessed and processed tissue.

Location

913 Industrial Drive Place, Vandalia, OH  45377

Benefits/Compensation

Job Summary of the EHS Specialist

The EHS Specialist will be responsible for supporting the development, implementation, maintenance, monitoring, and continuous improvement of our Environmental, Health and Safety Program. Ensure compliance with Local, State and Federal Regulatory Requirements.

Requirements of the EHS Specialist

• Bachelor’s degree in Occupational Health and Safety, Engineering, Safety Management, or closely related field
• 2+ years of experience in Environment, Health, and Safety (EHS)
• Knowledge of OSHA regulations specifically 29 CFR 1910
• High level of organizational and analytical skills.
• Proficient in using a computer and Microsoft Office (Outlook, Word, Excel, PowerPoint etc.).
• Strong interpersonal and communication skills to interact with multiple layers of the organization.
• Ability to work independently and be self-motivated.
• Ability to prioritize and manage multiple tasks, changing priorities as necessary.
• Ability to work under time pressure and adapt to changing requirements with a positive attitude.
• Ability to be self-motivated, proactive and an effective team player
• Experience in Lock Out / Tag out.

Responsibilities of the  EHS Specialist

The specific duties of the EHS Specialist include but are not limited to:

• Leads audits, inspections and investigations and coordinates resolution of issues.
• Works with management to facilitate risk management decisions.
• Develop and review Lockout / Tagout Procedures.
• Coordinate and Monitor Contractor Safety Program.
• Conduct regular walk through to monitor behaviors, activities, and conditions. Coach and mentor employees.
• Deliver environmental, health and safety trainings to ensure employee’s knowledge and understanding of safety and environmental regulations.
• Conduct Hazard Assessments and Ergonomic Evaluations.
• Review proposed new chemicals, processes, and equipment with the use of Management Change.
• Drive thorough investigations for all incidents and accidents and ensure timely completion of corrective actions. Lead the team in developing effective root cause analysis and countermeasures.
• Support with non-routine work permitting.
• Manage SDS Data Base and chemical inventory.
• Support SPCC, air emissions, wastewater and storm water, testing, monitoring, recordkeeping, and reporting requirements.
• Manage hazardous and medical waste program: documents, inspections, handling, storage, and disposal.
• Support with ISO14001 Implementation / Maintenance.
• Identify and support continuous improvement opportunities.

Location

913 Industrial Drive Place, Vandalia, OH 45377

Benefits/Compensation