Micro Lab Tech 1
Certified Laboratories Inc. job in Columbus, OH
Job Description
Certified Group is committed to delivering expert solutions and quality testing our customers can feel confident in - on time, every time - so the world can trust in what it consumes. As a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries.
We have embarked on an important journey to unify and strengthen our culture by living these core values: Start with the Customer, Drive to Deliver, Commit to Safety and Quality, and Believe in the Team - including believing in you.
We are currently looking for a Microbiology Technician to join our growing team!
JOB SUMMARY
Prepare samples for analytical and microbiological testing of food products, ingredients, and environmentals. The role is responsible for the application of approved microbiological techniques and methodologies used in analytical testing.
ESSENTIAL RESPONSIBILITIES
Prepare samples for indicator organisms, pathogens, and chemistries
Apply aseptic techniques in daily workload
Maintain media and reagents as needed for daily microbiological testing
Inventory and report expendable supplies/materials needed for testing requirements
Provide routine preventive maintenance by daily cleaning, sanitizing, and trash disposal
Perform quality control monitoring by taking incubator temperatures, inoculating control organisms, running media controls, etc.
Independently pursue an assigned series of processes, procedures, or techniques in accordance with FSNS policies/procedures and customer requirements
Maintain laboratory condition, to include equipment, supplies, quality assurance programs, and accurate records throughout all procedures
Perform all activities in a neat, safe, hygienic, and efficient manner
Share information in an open, and timely manner
Assisting with managing priorities and schedule such that individual goals as well as team goals are achieved with encouraged participation in the Food Safety Net Services Team
Responsible for the safety of oneself and others working within their area
Responsible for the completion of required training
MINIMUM QUALIFICATIONS
High School diploma or GED
Associate degree in Life Science or two years of laboratory experience, preferred
Broad knowledge of concepts, practices, and procedures of a food testing laboratory
Ability to travel is preferred
Or equivalent combination of education and experience
PHYSICAL DEMANDS
Dexterity of hands and fingers to operate a computer keyboard, mouse and to handle other communications/computer components
Potential exposure to odors, fumes, airborne particles, hazardous chemicals, and microbiological pathogens
Noise level varies from quiet to loud
Temperature varies from hot to cold
Interactive and fast-paced team oriented tasks
Occasionally lift and/or move up to 25 pounds.
Color vision and depth perception
Benefits:
Progressive 401k Retirement Savings Plan
Employer Paid Short- Term and Long-Term Disability, and Life Insurance
Group Medical
Tuition Reimbursement
Flexible Spending Accounts
Dental
Paid Holidays and Time Off
Certified Group values diversity in its workforce. The company is firmly committed to a policy of Equal Opportunity and will administer its policies in a manner that treats each employee and applicant for employment on the basis of merit. Certified Group will take affirmative action to seek out qualified applicants without regard to race, color, religion, sex, national origin, age, handicap, or veteran status.
Tuesday - Saturday, 2:00pm - 11:00 pm
Microbiology Operations Supervisor
Columbus, OH job
Columbus Regular MERIEUX NUTRISCIENCES As a trusted partner, our Public Health mission is to make food systems safer, healthier and more sustainable. Throughout our global network in 27 countries, we offer to our customers a wide range of testing and innovative solutions dedicated to preventing health risks related to food, environment and consumer goods. External growth has been a key pillar of our history with more than 40 acquisitions completed in the last 10 years.
If you want to contribute to an inspiring long-term purpose, to be part of a fast growing company on a high-value market with significant build-up opportunities, and to grow in an entrepreneurial and warm environment, join us!
YOUR DAY TO DAY LIFE
We are looking for a Microbiology Operations Supervisor in 2057 Builders Place, Columbus, OH 43204 USA. Your mission will be to:
The incumbent is responsible for the analysis of food sample. The incumbent supervises departmental personnel conducting routine analysis.
* Supervise the activities of departmental personnel to ensure operations are in accordance with Standard Operating Procedures and assigned tasks.
* Communicate any emerging client requirements to laboratory personnel as needed.
* Communicate procedural and operational difficulties and delays to client service personnel or the client as required.
* Read, calculate and record analysis data to produce a report for the client. Correct any discrepancies that occur.
* Administer corporate human resource programs relating to employee recruitment and retention, compensation, training and development, equal employment opportunity, performance appraisal, and employment record documentation.
* Educate and train departmental personnel on correct procedures and new analysis methods. Evaluate current methods and recommend modifications as new procedures become available.
* Arrange and document work schedules for departmental personnel so that analysis is accurately completed to maintain effective and efficient operations.
* Assist departmental personnel with analysis tasks as needed to ensure timely results.
* Maintain supplies and instrumentation for operating departments.
* Responsibility and authority, in conjunction with the Operations Manager or Lab Director, to cease specific analyses under their responsibility when evidence from the quality system indicated the process is not in control and the quality of the results is compromised as a result of the non-conformances.
* Maintain knowledge of Laboratory Information Management System (LIMS) that is required to complete job responsibilities.
* Ensure that employees obtain knowledge of LIMS sufficient to perform job responsibilities. Institute and maintain systems to monitor and verify related LIMS training.
* Maintain expertise in the field of food science by attending relevant seminars and using available reading material.
* Support corporate quality and continuous improvement process.
* This position has the responsibility and authority to initiate action to prevent or minimize departures from the quality system or test procedures. This authority includes addressing resource needs to properly address issues such as client turn-around time requirements, overtime limits, employee turnover, work stoppage and assure the appropriate type and amount of materials are ready and available for use.
* Perform other related tasks as needed
YOUR PROFILE
Profile (required education/qualifications and professional background): Bachelors degree and 2-5 years of relevant work experience or Masters degree. This position requires a broad knowledge of microbiology or chemistry, usually obtained from a degree in microbiology or chemistry, or through related job experience, to analyze and interpret data accurately. A general knowledge of food science is necessary to supervise the analysis of the sample.
Required skills: A broad knowledge of laboratory safety procedures and policies is necessary to ensure a safe working environment. A general knowledge of the Laboratory Information Management System is required to process client data and calculate and record analysis results.
Work Environment: The incumbent works in a laboratory setting with proper lighting and temperature control. Occasional exposure to laboratory fumes, chemicals, and materials will occur when in the laboratory. Safety equipment of gloves, laboratory coat and eyeglasses may need to be worn depending on the testing process. The incumbent may use the autoclave daily to complete the analysis process. Continuous lifting of analysis materials weighing up to 50 pounds are necessary to transport media materials. The incumbent can expect extended time spent in a standing position. The incumbent should be able to detect slight variation in shades of colors.
#LI-EK1
Compensation Package Overview:
Compensation Range: $65,000 - $70,000
Potential bonus: Up to 5% based on performance.
Full Time Eligible Benefits Overview:
Comprehensive medical, dental, and vision insurance plans.
Generous vacation package to support work-life balance following state and local ordinances.
The information above provides a general overview and may vary based on specific job responsibilities, location, or other factors. Details will be clarified during the hiring process.
WHY JOIN US?
* Because you would contribute to an inspiring Public Health purpose, supported by long-term and visionary shareholders.
* Because you would have an impact on our strategic pillars that build on 50 years of experience and expertise.
* Because you would be part of a community of an enthusiastic and skilled group of people who love co-building together and serving a purpose bigger than them.
* Because you would be welcome as you are, in a diverse and open-minded environment that is rich in our singularities and differences.
* Because you would grow in an international group of more than 8200 fantastic team members, with plenty of opportunities to learn and share.
Ready for the journey?
To apply please click on 'Apply now' button
Business Development Executive (NAMSA Talent Building Community)
Northwood, OH job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
Act with integrity in everything we do.
Provide best-in-class customer experiences.
Develop superior talent and deliver expertise.
Respond with agility and provide timely results.
Embrace collaboration, diverse perspectives and ideas.
Job Description:
• Develops and implements territory sales strategies with the ultimate goal of positioning NAMSA as the Medical Research Organization of choice.
• Achieves assigned sales goals in defined territory for NAMSA's Laboratory Services, Consulting Services and Clinical Services businesses.
• Remains ultimately responsible for all accounts within geographical territory, however, focus on increasing market share with Top Accounts. Top Accounts have been defined within each territory based on a global list and territory strategy
• Creates regular and effective interaction with existing and prospective Top Accounts, including field visits, phone, email, local or client specific meetings / events, national and global meetings / events, and any other tactical sales activity directed at growth of NAMSA's Laboratory Services, Consulting Services and Clinical Service businesses.
• Establishes, maintains, and enhances customer relationships.
• Recommends pricing and / or operational strategies to secure large pieces of new business with their respective Top Accounts
• Responsible for adding and maintaining information in CRM software per departmental procedures.
• Works with Strategic Partnership group to develop and implement NAMSA multi-year agreements.
• Supports manager, Business Development Specialists, Strategic Partner Team, and other sales & marketing professionals in developing new market opportunities in designated accounts and geographies.
• Prepares and delivers effective sales presentations and proposals to ensure successful outcome of sales interactions and transactions.
Qualifications & Technical Competencies:
• Bachelor's degree in business, sales, marketing, or scientific discipline required
• 3 to 5 years of outside, technical sales experience in a business to business sector preferred
• Experience selling CRO services or technical consulting services preferred; previous experience selling to the medical device industry highly desirable.
• Excellent written and verbal communication, organizational and time management skills
• Proficiency with Salesforce CRM (or ability to learn CRM software) and Microsoft Office applications
• Fluency in English and local language, if different, required
• Knowledge of Medical Devices or related Health Care Field
Working Conditions:
• 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Requires maintaining physical condition necessary for walking, standing, or sitting for prolonged periods of time.
• Extensive use of computer keyboard.
• Travels approximately 50%
Pay Range Minimum:
$81,100.00
Pay Range Target:
$120,000.00
Pay Frequency:
Annual
Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Fair Chance Employment Statement:
At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history.
Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position:
• May operate equipment
• Records data timely and accurately
• May analyze and interpret data
• Conducts studies on medical devices that have an impact on human life
A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
Auto-ApplySenior Histologist
Northwood, OH job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
* Act with integrity in everything we do.
* Provide best-in-class customer experiences.
* Develop superior talent and deliver expertise.
* Respond with agility and provide timely results.
* Embrace collaboration, diverse perspectives and ideas.
Job Description:
* Conduct general housekeeping of laboratory and clean slides.
* Dispose of biohazards, glass, sharps and other materials appropriately.
* Label slides and cassettes
* Box slides or samples for shipment to pathologists, archives and/or clients.
* Change processors and stainers.
* Bag/dispose of tissues for completed studies
* May perform tissue grossing for routine studies.
* Prepares microscopic slides for research/diagnostic purposes; includes fixation, dehydration, infiltration, embedding, microtomy, and mounting to include both paraffin and plastic processed tissues, in addition to frozen sectioning."
* Performs and maintains proficiency in histochemical staining procedures and troubleshooting techniques.
* Performs quality control procedures on all samples (slides, blocks, forms, etc.) to ensure accuracy and excellence.
* May develop procedures for tissue handling.
* Process tissues appropriately for review by a pathologist.
* May organize and participate in necropsies.
* May perform photography and high-resolution x-ray imaging and film developing.
* Maintains records according to good laboratory practices.
* Coordinates and performs the shipping of all pathology related specimens, including slides, blocks, and wet tissues, to the appropriate designated facility.
* May perform tissue trimming according to established guidelines.
* Maintains proficiency in all appropriate designated departmental SOPs with knowledge of lab processes.
* Maintains a clean, GLP-compliant lab and ensures all logbooks are reviewed and correct, and maintains laboratory equipment according to applicable SOPs.
* Performs calibration or validation activities applicable to specialized equipment.
* Assists with reviewing and revising histology-related SOPs and forms as necessary.
* Capable of conducting hard and soft plastics processing, embedding and staining.
* Assists in the completion of complicated client requests/projects.
* Trains new Associates on pathology techniques and on equipment SOPs.
* Other duties as assigned.
Qualifications & Technical Competencies:
* HT or HTL ASCP certification preferred.
* Six years of histology experience required, with four years' experience with plastic procedures preferred.
* Associate's degree and/or Bachelor's degree or equivalent in Biological Sciences or related discipline, with a degree in histology, or curriculum that includes hands-on histology techniques is preferred.
Working Conditions:
* While performing the duties of this job, the employee is regularly exposed to sharp objects, toxic or caustic chemicals, and a variety of livestock, domestic and laboratory animals. The employee is occasionally exposed to fluoroscopy and biohazards such as blood borne pathogens and zoonotic diseases.
* The noise level in the work environment is usually quiet.
* While performing the duties of this job, the employee is regularly required to stand, reach with hands and arms, and use hands to finger, handle, or feel objects, tools or controls; talk or hear; and work/type at a computer. The employee is frequently required to walk and sit. The employee is regularly required to use hand-held cutting knives and blades for precise cutting of materials. The employee must occasionally lift and/or move up to 50 pounds and up to 75 pounds with assistance. Employee may be required to view computer monitors, look through microscopes and stand for extended periods of time.
* Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and the ability to adjust focus.
Auto-ApplyAnimal Care Technician (Weekends required)
Northwood, OH job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
Act with integrity in everything we do.
Provide best-in-class customer experiences.
Develop superior talent and deliver expertise.
Respond with agility and provide timely results.
Embrace collaboration, diverse perspectives and ideas.
Job Description:
• Follows the Quality Manual, all NAMSA SOPs, and Process documents.
• Primarily involved in the welfare and husbandry activities of animals, including sanitation of equipment and the vivarium.
• May operate a variety of cleaning equipment such as pressure hoses and cage washers.
• Administers daily and enrichment feeding according to SOP or protocol prescribed amounts and types of feed. Assesses and documents appetite and feces patterns.
• Interacts with animals daily and sets up or participates in animal enrichment activities.
• Performs animal receipt, including preparing housing for arrival, movement of animals to housing, preparing animal charts, and bathing and weighing of animals as required. May perform microchipping/tail-marking depending upon species.
• Performs daily documentation activities, such as cleaning/sprayback and feeding dates and times, sanitation dates and initials, appetite, feces and vomit observations, room and location transfers, room temperature and humidity data, etc.
• Weighs animals according to schedule or as dictated by study protocol.
• May conduct training on husbandry tasks for other Associates and update training records.
• May assist during the conduct of animal procedures, assays, or other activities conducted in the vivariums by helping hold or restrain animals as needed.
• Performs preventive health maintenance such as ear cleaning, teeth trimming, nail trimming, skin greasing, and bathing depending upon species.
• Conducts animal movement from room to room as needed for housing requirements, study requirements, cleaning, etc. May use transport cart to assist with moving large post-operative animals
• May administer treatments and medications under direction of a Veterinarian.
• Assists with stocking animal and surgical supplies.
• Other duties as assigned.
Qualifications & Technical Competencies:
Principal Duties and Responsibilities
Primarily involved in the welfare and husbandry activities of animals, including sanitation of equipment and the vivarium
Receives, identifies, and acclimates laboratory animals.
May euthanize animals.
May administer medications under the direction of a Veterinarian.
Follows the Quality Manual, all NAMSA SOPs, and Process documents.
Documents all required tasks.
May administer treatments as directed by staff veterinarian.
May conduct training on husbandry tasks for other Associates and update training records.
Other duties as assigned.
Qualifications and Skills
High School Diploma or equivalent.
0-2 years of related experience.
Technical Competencies
Awareness of applicable federal guidelines and regulations including but not limited to USP, ISO, CTFA, FSA, the Guide for the Care and Use of Laboratory Animals, and the Animal Welfare Act.
Knowledge of metric system, NAMSA GLP testing, scientific applications, experimental design, and data evaluation.
Ability to use applicable NAMSA applications.
Working Conditions
Physical activities include standing, walking, sitting, climbing a ladder, using hands to finger, handle, feel or cut using various tools, and reaching with hands and arms.
Vision abilities required include close vision, color vision, depth perception, and ability to adjust focus.
Physical requirements include the ability to frequently lift and move 50 lbs. (23 kgs.) or more on occasion.
Employee must be able to talk and hear.
May be required to be on-call for weekends and holidays. The associate will respond in accordance with the criteria outlined in The Associate Handbook.
Working Conditions:
• While performing the duties of this job, the employee is regularly exposed to, and must handle and come in contact with, a variety of large and small livestock, domestic and laboratory animals, is regularly exposed to non-weather wet conditions and toxic or caustic chemicals, and is frequently exposed to outdoor weather conditions. The employee is occasionally required to work with radioactive isotopes and in a Bio-Safety-Level 2 (BSL2) environment, and is occasionally exposed to gasses such as CO2 and isoflurane. The employee may occasionally be exposed to fluoroscopy, blood borne pathogens and zoonotic diseases.
• The noise level in the work environment is usually moderate and frequently loud. Hearing protection is required in designated areas and when performing specific tasks.
• While performing the duties of this job, the employee is regularly required to stand, walk, reach with hands and arms, use hands, talk and hear. The employee is frequently required to grip and squeeze with hands, stoop, kneel or crouch. The employee is occasionally required to sit, climb or balance, or crawl.
• The employee is regularly required to lift up to 50 pounds unassisted. The employee is occasionally required to physically restrain up to 80 pounds unassisted, and to maneuver and/or restrain up to 220 pounds with the assistance of other personnel and/or other maneuvering/restraining devices.
NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Auto-ApplyStudy Director (NAMSA Talent Building Community)
Northwood, OH job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
* Act with integrity in everything we do.
* Provide best-in-class customer experiences.
* Develop superior talent and deliver expertise.
* Respond with agility and provide timely results.
* Embrace collaboration, diverse perspectives and ideas.
Job Description:
* Assists in the coordination of study conduct tasks from study initiation to study completion.
* Performs noncomplex studies and serves as the primary contact for the client, as assigned, and keeps the client informed of schedule and any unforeseen events or issues.
* Performs project in compliance with applicable quality system regulations (i.e. ISO, GMP, GLP) and NAMSA SOPs.
* Knows and understands the Animal Welfare Requirements and serves as Principal Investigator, when applicable.
* Serves as the Study Director for GLP and non-GLP preclinical studies and assures that all applicable GLP regulations are followed.
* May need to participate in study specific procedures.
* Evaluates, analyzes and interprets data and presents in a clear, well-organized, scientifically sound report.
* Assures that all data including unanticipated responses are accurately recorded, verified and organized.
* May need to ensure that study records for GLP studies are archived upon completion of the study.
* May need to interact with regulatory bodies (i.e. FDA, NMPA, ANSM, etc)
* Prepares protocol submissions for IACUC review and responds to committee comments/questions as necessary.
* Interacts as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
* Participates in client discussions regarding study design when needed.
* Develops and leads moderately complex study designs as needed, serves as the primary contact for the client as assigned, and keeps the client informed of schedule and any unforeseen events or issues.
* Establishes and ensures schedule, budget and quality commitments are met for the client.
* Manages (motivates, communicates) internal multidisciplinary team members to ensure that client expectations are met.
* Understands investigational product(s) including high-level understanding of the Medical Device Development Process.
* Evaluates, analyzes, and interprets study data and presents in a clear, well-organized, scientifically sound report.
* Assists with departmental training as needed.
* Other duties as assigned.
Qualifications & Technical Competencies:
* Requires a minimum of a Bachelor's degree, preferably in a scientific discipline, with a minimum of two years' related laboratory experience.
* Master's degree/PhD with a minimum of one year of relevant laboratory experience.
Working Conditions:
* While performing the duties of this job, the Associate is regularly exposed to general office conditions, and will be required to regularly work on personal computers and keyboards. The Associate is frequently exposed to a variety of livestock, domestic and laboratory animals and to fluoroscopy and faxitron x-ray imaging. The Associate is occasionally exposed to sharp objects, radioactive isotopes, gasses such as CO2 and isoflurane, toxic or caustic chemicals, and a Bio-Safety-Level 2 (BSL2) environment. On rare occasions, the Associate may be exposed to zoonotic diseases and blood borne pathogens.
* The noise level in the work environment is usually moderate.
* While performing the duties of this job, the Associate is regularly required to sit, stand, walk, use hands and fingers, reach with hands and arms, talk and hear, use computer keyboard, and view computer monitors. The Associate must occasionally lift and/or move up to 50 pounds.
* Specific vision abilities required by this job include close vision, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination.
NAMSA is an equal employment opportunity company.
NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Auto-ApplyVet Tech - Large and Small Animal (NAMSA Talent Building Community)
Northwood, OH job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
* Act with integrity in everything we do.
* Provide best-in-class customer experiences.
* Develop superior talent and deliver expertise.
* Respond with agility and provide timely results.
* Embrace collaboration, diverse perspectives and ideas.
Job Description:
* Performs dosing of test agents in small animals through a variety of dosing methods, including, but not limited to, intraperitoneal, intravenous, epicutaneous, intradermal, subcutaneous, intramuscular, and oral. Applies topical test agents as required.
* Performs scoring of test agents, assessing the subject's reaction to the agent.
* Performs post-procedure small animal euthanasia following established protocols.
* Performs and documents a variety of activities, including but not limited to, routine clinical observations, charting of physiological data and animal health status, taking study-required animal weights, etc.
* Assists with preparing animals for surgery and with administering and monitoring anesthesia during procedure and post-operatively. Performs incision monitoring, pain assessment and medication administration as needed post-procedurally.
* Performs intravenous and cardiac blood collection.
* Performs preventive health maintenance such as nail trims and bathing.
* Performs all aspects of veterinary directed care and general husbandry procedures according to established procedures, guidelines and study protocols that meet the acceptable criteria of the veterinarian. Administers medications as prescribed by veterinarian and/or protocol specifications.
* Communicates with Veterinarian and Study Director regarding living conditions and medical status of animals.
* Cleans and maintains routinely utilized equipment.
* Assists with other duties as assigned.
Qualifications & Technical Competencies:
* Certified Veterinary Technician (CVT) or ALAT certification is preferred.
* Bachelor's degree in scientific discipline or Associate of Science in Veterinary Technology required or equivalent through experience in lieu of education.
Working Conditions:
* While performing the duties of this job, the employee is regularly exposed to, and must handle and come in contact with, a variety of small laboratory animals. The employee is frequently exposed to sharps, wet conditions (non-weather), gasses such as CO2 and isoflurane, and toxic or caustic chemicals. The employee is occasionally required to work with radioactive isotopes and in a Bio-Safety-Level 2 (BSL2) environment and may, on rare occasion, be exposed to zoonotic diseases.
* The noise level in the work environment is usually moderate and occasionally loud
* While performing the duties of this job, the employee is regularly required to stand, walk, use hands, and talk or hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to sit, climb or balance, and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 20 pounds, and occasionally lift and/or move up to 75 pounds with assistance. The employee may be required to view computer monitors and stand for extended periods of time.
* Specific vision abilities required by this job include close vision, the ability to see a full range of colors, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination.
NAMSA is an equal employment opportunity company.
NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Auto-ApplyClinical Research Associate - NAMSA Future Openings USA
Northwood, OH job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
Act with integrity in everything we do.
Provide best-in-class customer experiences.
Develop superior talent and deliver expertise.
Respond with agility and provide timely results.
Embrace collaboration, diverse perspectives and ideas.
Job Description:
• Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.
• Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
• May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.
• Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed.
• Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.
• Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
• Performs study-related training.
• Manages the development and maintenance of study documents, processes and systems as assigned.
• Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals.
• Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance.
• Attends internal and external meetings as required.
• Provides all job-related progress reports and visit documentation as required.
• May support safety activities such as narrative writing, managing the CEC/DSMB, etc.
• OUS: Prepares and coordinates submissions to regulatory authorities.
• May perform other activities as assigned.
Qualifications & Technical Competencies:
• Fluency in English and local language, if different, required.
• Higher education degree or equivalent education, training, and experience.
• Preferred 2 years clinical trial experience.
• Preferred monitoring experience.
• Able to work independently once trained.
• Good verbal and written communication skills.
• Strong organizational skills.
• Basic computer proficiency.
• Understanding of clinical research processes and regulations.
• Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required
Working Conditions:
• Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates.
• 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
• Extensive use of a computer keyboard.
Pay Range Minimum:
$54,400.00
Pay Range Target:
$80,100.00
Pay Frequency:
Annual
Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Fair Chance Employment Statement:
At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history.
Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position:
• May operate equipment
• Records data timely and accurately
• May analyze and interpret data
• Conducts studies on medical devices that have an impact on human life
A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
Auto-ApplyHistology Professionals (NAMSA Talent Building Community)
Northwood, OH job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
* Act with integrity in everything we do.
* Provide best-in-class customer experiences.
* Develop superior talent and deliver expertise.
* Respond with agility and provide timely results.
* Embrace collaboration, diverse perspectives and ideas.
Job Description:
* Conduct general housekeeping of laboratory and clean slides.
* Dispose of biohazards, glass, sharps and other materials appropriately.
* Label slides and cassettes
* Box slides or samples for shipment to pathologists, archives and/or clients.
* Change processors and stainers.
* Bag/dispose of tissues for completed studies
* May perform tissue grossing for routine studies.
* Prepares microscopic slides for research/diagnostic purposes; includes fixation, dehydration, infiltration, embedding, microtomy and mounting to include both paraffin and plastic processed tissues, in addition to frozen sectioning."
* Performs and maintains proficiency in histochemical staining procedures and troubleshooting techniques.
* Performs quality control procedures on all samples (slides, blocks, forms, etc.) to ensure accuracy and excellence.
* May develop procedures for tissue handling.
* Process tissues appropriately for review by a pathologist.
* May organize and participate in necropsies.
* May perform photography and high-resolution x-ray imaging and film developing.
* Maintains records according to good laboratory practices.
* Coordinates and performs the shipping of all pathology related specimens, including slides, blocks, and wet tissues, to the appropriate designated facility.
* May perform tissue trimming according to established guidelines.
* Maintains proficiency in all appropriate designated departmental SOPs with knowledge of lab processes.
* Maintains a clean, GLP-compliant lab and ensures all logbooks are reviewed and correct, and maintains laboratory equipment according to applicable SOPs.
* Performs calibration or validation activities applicable to specialized equipment.
* Other duties as assigned.
Qualifications & Technical Competencies:
Qualifications & Technical Competencies
* HT or HTL ASCP certification preferred.
* Two years histology experience required, with one year experience with plastic procedures preferred.
* Associate's degree and/or Bachelor's degree or equivalent in Biological Sciences or related discipline, with a degree in histology, or curriculum that includes hands-on histology techniques is preferred.
Working Conditions:
Working Conditions
* While performing the duties of this job, the employee is regularly exposed to sharp objects, toxic or caustic chemicals, and a variety of livestock, domestic and laboratory animals. The employee is occasionally exposed to fluoroscopy and biohazards such as blood borne pathogens and zoonotic diseases.
* The noise level in the work environment is usually quiet..
* While performing the duties of this job, the employee is regularly required to stand, reach with hands and arms, and use hands to finger, handle, or feel objects, tools or controls; talk or hear; and work/type at a computer. The employee is frequently required to walk and sit. The employee is regularly required to use hand-held cutting knives and blades for precise cutting of materials. The employee must occasionally lift and/or move up to 50 pounds and up to 75 pounds with assistance. Employee may be required to view computer monitors, look through microscopes and stand for extended periods of time.
* Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and the ability to adjust focus.
Pay Range Minimum:
$37,000.00
Pay Range Target:
$54,000.00
Pay Frequency:
Annual
Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
NAMSA is an equal employment opportunity company.
NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Auto-ApplyLaboratory Assistant - Media
Columbus, OH job
Columbus Regular MERIEUX NUTRISCIENCES As a trusted partner, our Public Health mission is to make food systems safer, healthier and more sustainable. Throughout our global network in 27 countries, we offer to our customers a wide range of testing and innovative solutions dedicated to preventing health risks related to food, environment and consumer goods. External growth has been a key pillar of our history with more than 40 acquisitions completed in the last 10 years.
If you want to contribute to an inspiring long-term purpose, to be part of a fast growing company on a high-value market with significant build-up opportunities, and to grow in an entrepreneurial and warm environment, join us!
YOUR DAY TO DAY LIFE
We are looking for a Laboratory Assistant - Media in 2057 Builders Place, Columbus, OH 43204 USA. Your mission will be to:
Sunday - Thursday Schedule
* Aseptically prepare and dispense various types of sterile media: liquid (broths) and solid (agars) culture media into designated containers (vessels), ensuring precise volumes in accordance with established Standard Operating Procedures (SOPs).
* Execute comprehensive decontamination of laboratory waste
* Cleaning and sanitizing department laboratory surfaces (countertops, walls, floors, shelves, sinks, water baths) and equipment using specified cleaning agents and solvents.
* Manage laboratory inventory by maintaining an adequate stock of all materials, chemicals, and reagents needed for lab testing, and ensure their proper and safe storage.
* Execute sterility and growth promotion testing on incoming and in-house media batches per internal testing specifications.
* Record data in a cloud-based asset and compliance management software system.
* Maintain knowledge of the Laboratory Information Management System (LIMS) that is required to complete job responsibilities.
* Perform daily, weekly verification on equipment needed for analysis.
* Support corporate quality and continuous improvement processes.
* Participate in the established cleaning schedule and maintain lab cleanliness.
* Adhere to all safety policies and support laboratory management in the implementation, maintenance, and improvement of the management system.
* Perform daily bottom blowdown procedures on boilers to remove sediment and control water quality, following all safety protocols and valve sequencing procedures.
* All other tasks as needed
YOUR PROFILE
Sunday - Thursday Schedule
Highschool diploma or GED or equivalent work experience.
Required skills:
* Attention to Detail
* Communication & Teamwork
* Organizational Skills & Time Management
* Problem-Solving & Adaptability
* Reliability & Dependability
Physical Requirements:
* Routinely moves throughout the laboratory and storage areas, which includes standing for extended periods, bending, stooping, and reaching to access materials and perform duties.
* This position requires physical exertion, including frequently moving materials.
Work Environment: The incumbent works in a laboratory setting with proper lighting and temperature control. Occasional exposure to laboratory fumes, chemicals, and materials will occur when in the laboratory. Safety equipment of gloves, laboratory coat and eyeglasses may need to be worn depending on the testing process. The incumbent may use the autoclave daily to complete the analysis process. Continuous lifting of analysis materials weighing up to 50 pounds are necessary to transport media materials. The incumbent can expect extended time spent in a standing position. The incumbent should be able to detect slight variation in shades of colors.
WHY JOIN US?
* Because you would contribute to an inspiring Public Health purpose, supported by long-term and visionary shareholders.
* Because you would have an impact on our strategic pillars that build on 50 years of experience and expertise.
* Because you would be part of a community of an enthusiastic and skilled group of people who love co-building together and serving a purpose bigger than them.
* Because you would be welcome as you are, in a diverse and open-minded environment that is rich in our singularities and differences.
* Because you would grow in an international group of more than 8200 fantastic team members, with plenty of opportunities to learn and share.
Ready for the journey?
To apply please click on 'Apply now' button
Senior Histologist
Northwood, OH job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
Act with integrity in everything we do.
Provide best-in-class customer experiences.
Develop superior talent and deliver expertise.
Respond with agility and provide timely results.
Embrace collaboration, diverse perspectives and ideas.
Job Description:
• Conduct general housekeeping of laboratory and clean slides.
• Dispose of biohazards, glass, sharps and other materials appropriately.
• Label slides and cassettes
• Box slides or samples for shipment to pathologists, archives and/or clients.
• Change processors and stainers.
• Bag/dispose of tissues for completed studies
• May perform tissue grossing for routine studies.
• Prepares microscopic slides for research/diagnostic purposes; includes fixation, dehydration, infiltration, embedding, microtomy, and mounting to include both paraffin and plastic processed tissues, in addition to frozen sectioning."
• Performs and maintains proficiency in histochemical staining procedures and troubleshooting techniques.
• Performs quality control procedures on all samples (slides, blocks, forms, etc.) to ensure accuracy and excellence.
• May develop procedures for tissue handling.
• Process tissues appropriately for review by a pathologist.
• May organize and participate in necropsies.
• May perform photography and high-resolution x-ray imaging and film developing.
• Maintains records according to good laboratory practices.
• Coordinates and performs the shipping of all pathology related specimens, including slides, blocks, and wet tissues, to the appropriate designated facility.
• May perform tissue trimming according to established guidelines.
• Maintains proficiency in all appropriate designated departmental SOPs with knowledge of lab processes.
• Maintains a clean, GLP-compliant lab and ensures all logbooks are reviewed and correct, and maintains laboratory equipment according to applicable SOPs.
• Performs calibration or validation activities applicable to specialized equipment.
• Assists with reviewing and revising histology-related SOPs and forms as necessary.
• Capable of conducting hard and soft plastics processing, embedding and staining.
• Assists in the completion of complicated client requests/projects.
• Trains new Associates on pathology techniques and on equipment SOPs.
• Other duties as assigned.
Qualifications & Technical Competencies:
• HT or HTL ASCP certification preferred.
• Six years of histology experience required, with four years' experience with plastic procedures preferred.
• Associate's degree and/or Bachelor's degree or equivalent in Biological Sciences or related discipline, with a degree in histology, or curriculum that includes hands-on histology techniques is preferred.
Working Conditions:
• While performing the duties of this job, the employee is regularly exposed to sharp objects, toxic or caustic chemicals, and a variety of livestock, domestic and laboratory animals. The employee is occasionally exposed to fluoroscopy and biohazards such as blood borne pathogens and zoonotic diseases.
• The noise level in the work environment is usually quiet.
• While performing the duties of this job, the employee is regularly required to stand, reach with hands and arms, and use hands to finger, handle, or feel objects, tools or controls; talk or hear; and work/type at a computer. The employee is frequently required to walk and sit. The employee is regularly required to use hand-held cutting knives and blades for precise cutting of materials. The employee must occasionally lift and/or move up to 50 pounds and up to 75 pounds with assistance. Employee may be required to view computer monitors, look through microscopes and stand for extended periods of time.
• Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and the ability to adjust focus.
Auto-ApplyAnimal Care Technician (Weekends required)
Northwood, OH job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
* Act with integrity in everything we do.
* Provide best-in-class customer experiences.
* Develop superior talent and deliver expertise.
* Respond with agility and provide timely results.
* Embrace collaboration, diverse perspectives and ideas.
Job Description:
* Follows the Quality Manual, all NAMSA SOPs, and Process documents.
* Primarily involved in the welfare and husbandry activities of animals, including sanitation of equipment and the vivarium.
* May operate a variety of cleaning equipment such as pressure hoses and cage washers.
* Administers daily and enrichment feeding according to SOP or protocol prescribed amounts and types of feed. Assesses and documents appetite and feces patterns.
* Interacts with animals daily and sets up or participates in animal enrichment activities.
* Performs animal receipt, including preparing housing for arrival, movement of animals to housing, preparing animal charts, and bathing and weighing of animals as required. May perform microchipping/tail-marking depending upon species.
* Performs daily documentation activities, such as cleaning/sprayback and feeding dates and times, sanitation dates and initials, appetite, feces and vomit observations, room and location transfers, room temperature and humidity data, etc.
* Weighs animals according to schedule or as dictated by study protocol.
* May conduct training on husbandry tasks for other Associates and update training records.
* May assist during the conduct of animal procedures, assays, or other activities conducted in the vivariums by helping hold or restrain animals as needed.
* Performs preventive health maintenance such as ear cleaning, teeth trimming, nail trimming, skin greasing, and bathing depending upon species.
* Conducts animal movement from room to room as needed for housing requirements, study requirements, cleaning, etc. May use transport cart to assist with moving large post-operative animals
* May administer treatments and medications under direction of a Veterinarian.
* Assists with stocking animal and surgical supplies.
* Other duties as assigned.
Qualifications & Technical Competencies:
Principal Duties and Responsibilities
* Primarily involved in the welfare and husbandry activities of animals, including sanitation of equipment and the vivarium
* Receives, identifies, and acclimates laboratory animals.
* May euthanize animals.
* May administer medications under the direction of a Veterinarian.
* Follows the Quality Manual, all NAMSA SOPs, and Process documents.
* Documents all required tasks.
* May administer treatments as directed by staff veterinarian.
* May conduct training on husbandry tasks for other Associates and update training records.
* Other duties as assigned.
Qualifications and Skills
* High School Diploma or equivalent.
* 0-2 years of related experience.
Technical Competencies
* Awareness of applicable federal guidelines and regulations including but not limited to USP, ISO, CTFA, FSA, the Guide for the Care and Use of Laboratory Animals, and the Animal Welfare Act.
* Knowledge of metric system, NAMSA GLP testing, scientific applications, experimental design, and data evaluation.
* Ability to use applicable NAMSA applications.
Working Conditions
* Physical activities include standing, walking, sitting, climbing a ladder, using hands to finger, handle, feel or cut using various tools, and reaching with hands and arms.
* Vision abilities required include close vision, color vision, depth perception, and ability to adjust focus.
* Physical requirements include the ability to frequently lift and move 50 lbs. (23 kgs.) or more on occasion.
* Employee must be able to talk and hear.
* May be required to be on-call for weekends and holidays. The associate will respond in accordance with the criteria outlined in The Associate Handbook.
Working Conditions:
* While performing the duties of this job, the employee is regularly exposed to, and must handle and come in contact with, a variety of large and small livestock, domestic and laboratory animals, is regularly exposed to non-weather wet conditions and toxic or caustic chemicals, and is frequently exposed to outdoor weather conditions. The employee is occasionally required to work with radioactive isotopes and in a Bio-Safety-Level 2 (BSL2) environment, and is occasionally exposed to gasses such as CO2 and isoflurane. The employee may occasionally be exposed to fluoroscopy, blood borne pathogens and zoonotic diseases.
* The noise level in the work environment is usually moderate and frequently loud. Hearing protection is required in designated areas and when performing specific tasks.
* While performing the duties of this job, the employee is regularly required to stand, walk, reach with hands and arms, use hands, talk and hear. The employee is frequently required to grip and squeeze with hands, stoop, kneel or crouch. The employee is occasionally required to sit, climb or balance, or crawl.
* The employee is regularly required to lift up to 50 pounds unassisted. The employee is occasionally required to physically restrain up to 80 pounds unassisted, and to maneuver and/or restrain up to 220 pounds with the assistance of other personnel and/or other maneuvering/restraining devices.
NAMSA is an equal employment opportunity company.
NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Auto-ApplyBusiness Development Executive (NAMSA Talent Building Community)
Northwood, OH job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
* Act with integrity in everything we do.
* Provide best-in-class customer experiences.
* Develop superior talent and deliver expertise.
* Respond with agility and provide timely results.
* Embrace collaboration, diverse perspectives and ideas.
Job Description:
* Develops and implements territory sales strategies with the ultimate goal of positioning NAMSA as the Medical Research Organization of choice.
* Achieves assigned sales goals in defined territory for NAMSA's Laboratory Services, Consulting Services and Clinical Services businesses.
* Remains ultimately responsible for all accounts within geographical territory, however, focus on increasing market share with Top Accounts. Top Accounts have been defined within each territory based on a global list and territory strategy
* Creates regular and effective interaction with existing and prospective Top Accounts, including field visits, phone, email, local or client specific meetings / events, national and global meetings / events, and any other tactical sales activity directed at growth of NAMSA's Laboratory Services, Consulting Services and Clinical Service businesses.
* Establishes, maintains, and enhances customer relationships.
* Recommends pricing and / or operational strategies to secure large pieces of new business with their respective Top Accounts
* Responsible for adding and maintaining information in CRM software per departmental procedures.
* Works with Strategic Partnership group to develop and implement NAMSA multi-year agreements.
* Supports manager, Business Development Specialists, Strategic Partner Team, and other sales & marketing professionals in developing new market opportunities in designated accounts and geographies.
* Prepares and delivers effective sales presentations and proposals to ensure successful outcome of sales interactions and transactions.
Qualifications & Technical Competencies:
* Bachelor's degree in business, sales, marketing, or scientific discipline required
* 3 to 5 years of outside, technical sales experience in a business to business sector preferred
* Experience selling CRO services or technical consulting services preferred; previous experience selling to the medical device industry highly desirable.
* Excellent written and verbal communication, organizational and time management skills
* Proficiency with Salesforce CRM (or ability to learn CRM software) and Microsoft Office applications
* Fluency in English and local language, if different, required
* Knowledge of Medical Devices or related Health Care Field
Working Conditions:
* 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* Requires maintaining physical condition necessary for walking, standing, or sitting for prolonged periods of time.
* Extensive use of computer keyboard.
* Travels approximately 50%
Pay Range Minimum:
$81,100.00
Pay Range Target:
$120,000.00
Pay Frequency:
Annual
Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
NAMSA is an equal employment opportunity company.
NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Fair Chance Employment Statement:
At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history.
Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position:
* May operate equipment
* Records data timely and accurately
* May analyze and interpret data
* Conducts studies on medical devices that have an impact on human life
A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
Auto-ApplySenior Lab Technologist-In Vitro (Sign on Bonus Eligible)
Northwood, OH job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
Act with integrity in everything we do.
Provide best-in-class customer experiences.
Develop superior talent and deliver expertise.
Respond with agility and provide timely results.
Embrace collaboration, diverse perspectives and ideas.
Job Description:
• Executes routine testing per NAMSA SOPs, with appropriate data analysis (cytotoxicity, hemocompatibility and genotoxicity).
• Strictly adheres to GLP guidelines (good documentation, labeling and expiration of materials, participation in audits).
• Performs maintenance of cell lines through propagation, cell concentration and viability determination, and creation of plates used for standard testing.
• Performs the extraction process on prepared samples in accordance to ISO, USP and/or JMHLW regulations as directed by study protocol for biocompatibility assays.
• Communicates with clients in regards to particulate observations or article abnormalities. Routinely communicates with Study Directors and Quality Assurance about issues, results, or audits.
• Operates, cleans and maintains incubators, autoclaves, hoods, and other equipment routinely utilized.
• Performs preparation of media/reagents, maintains reagents and/or test article as required for testing, and maintains lab supplies/inventory.
• Performs data entry, routine calculations, analysis and interpretation of results, and routes all positive results or unusual testing occurrences to Management and/or the Study Director.
• May assist associates with performing routine test article/product preparation according to work instructions.
• Assist with creating and communicating schedules for the Associates appropriate for the lab workload. Provide any scheduling updates to NAMSA Associates or management as needed.
• Maintains ancillary records (logbooks, worksheets).
• May be required to perform personal gowning, environmental testing, and submit organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing.
• Adheres to established company processes.
• May provide administrative support.
• May prepare and maintain sterile glassware for the In-vitro lab and sample preparation process. Processes glassware through washer, autoclave and depyrogenation oven as needed.
• Completes chain of custody documentation for test article tracking.
• Responsible for daily monitoring of laboratory equipment, being on-call and responding to continuous monitoring alarms. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures.
• Assist with ordering and/or stocking supplies subject to approval
• May be certified as a trainer to provide Associates with on the job training. Documents training activities and completes certification of Associates. Trains Associates on Hemocompatibility and Cytotoxicity.
• Conduct routine studies independently. May be requested to conduct more involved custom studies.
• Participate in the creation and improvement of documents, test systems, quality systems, and workflow.
• May perform Environmental Monitoring, clean and disinfect cleanroom suites.
• Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management as required.
• May conduct genotoxicity testing.
• Other duties as assigned
Qualifications & Technical Competencies:
Principal Duties and Responsibilities
May perform routine test article/product preparation according to work instructions.
May execute routine testing per NAMSA SOPs, with appropriate data analysis.
Performs routine calculations, interprets results, and can route all positive results or unusual testing occurrences to Management.
May provide on the job training.
Assure testing/test article preparation is performed within due dates.
May prepare and maintain cell lines and reagents required for testing, as applicable for primary department.
Ensures all testing/test article preparation is conducted according to the written instructions.
Maintain ancillary records (logbooks, worksheets).
Conduct routine studies fully independently.
Is routinely involved with the conduct of more involved in both study design and execution of more complex studies, as required by primary department.
Participate in the development and improvement of documents, test systems, quality systems, and workflow.
Conducts genotoxicity testing.
May be responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms. If needed, the associate will respond in accordance with criteria outlined in Standard Operating Procedures.
May order and/or stock supplies subject to approval.
May perform environmental monitoring and trend data.
May review reagent preparation worksheets, raw data, and documentation as applicable per primary department.
May be required to operate autoclave.
Qualifications and Skills
Bachelor's degree in scientific discipline appropriate for hiring department and at least three years of related laboratory experience.
Technical Competencies
Awareness of applicable guidelines and regulations appropriate for primary department, these may include USP, ISO, CTFA, FSA, ICH, EP, and/or JP.
Knowledge of metric system, scientific applications, experimental design, and data evaluation.
Can write technical documents and communications (SOPs, protocols, Trackwise records) with minimal management input.
Proficient at applicable NAMSA systems (LIMS, Trackwise, MasterControl, etc.) as appropriate per primary department.
Ability to work in GMP/GLP environment.
Working Conditions
Physical activities include standing, walking, sitting, using hands to finger, handle, or feel, and reaching with hands and arms. Occasionally required to climb or balance.
Vision abilities required include close vision, color vision, depth perception, and ability to adjust focus.
Physical requirements include frequently lifting up to 25 pounds or more on occasion.
Employee must be able to talk and hear.
Working Conditions:
• While performing the duties of this job, the employee is regularly exposed to sharps, human and animal blood, and hazardous or caustic chemicals. The noise level in the work environment is usually moderate. Safety glasses and hearing protection are required in designated areas and when performing specific tasks.
• "While performing the duties of this job, the employee is regularly required to stand, walk, use hands, talk and hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to sit, climb or balance, and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 50 pounds, and occasionally lift and/or move up to 75 pounds with assistance. The employee may be required to view computer monitors and stand for extended periods of time.
• Specific vision abilities required by this job include close vision, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination"
NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Auto-ApplyStudy Director (NAMSA Talent Building Community)
Northwood, OH job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
Act with integrity in everything we do.
Provide best-in-class customer experiences.
Develop superior talent and deliver expertise.
Respond with agility and provide timely results.
Embrace collaboration, diverse perspectives and ideas.
Job Description:
• Assists in the coordination of study conduct tasks from study initiation to study completion.
• Performs noncomplex studies and serves as the primary contact for the client, as assigned, and keeps the client informed of schedule and any unforeseen events or issues.
• Performs project in compliance with applicable quality system regulations (i.e. ISO, GMP, GLP) and NAMSA SOPs.
• Knows and understands the Animal Welfare Requirements and serves as Principal Investigator, when applicable.
• Serves as the Study Director for GLP and non-GLP preclinical studies and assures that all applicable GLP regulations are followed.
• May need to participate in study specific procedures.
• Evaluates, analyzes and interprets data and presents in a clear, well-organized, scientifically sound report.
• Assures that all data including unanticipated responses are accurately recorded, verified and organized.
• May need to ensure that study records for GLP studies are archived upon completion of the study.
• May need to interact with regulatory bodies (i.e. FDA, NMPA, ANSM, etc)
• Prepares protocol submissions for IACUC review and responds to committee comments/questions as necessary.
• Interacts as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
• Participates in client discussions regarding study design when needed.
• Develops and leads moderately complex study designs as needed, serves as the primary contact for the client as assigned, and keeps the client informed of schedule and any unforeseen events or issues.
• Establishes and ensures schedule, budget and quality commitments are met for the client.
• Manages (motivates, communicates) internal multidisciplinary team members to ensure that client expectations are met.
• Understands investigational product(s) including high-level understanding of the Medical Device Development Process.
• Evaluates, analyzes, and interprets study data and presents in a clear, well-organized, scientifically sound report.
• Assists with departmental training as needed.
• Other duties as assigned.
Qualifications & Technical Competencies:
• Requires a minimum of a Bachelor's degree, preferably in a scientific discipline, with a minimum of two years' related laboratory experience.
• Master's degree/PhD with a minimum of one year of relevant laboratory experience.
Working Conditions:
• While performing the duties of this job, the Associate is regularly exposed to general office conditions, and will be required to regularly work on personal computers and keyboards. The Associate is frequently exposed to a variety of livestock, domestic and laboratory animals and to fluoroscopy and faxitron x-ray imaging. The Associate is occasionally exposed to sharp objects, radioactive isotopes, gasses such as CO2 and isoflurane, toxic or caustic chemicals, and a Bio-Safety-Level 2 (BSL2) environment. On rare occasions, the Associate may be exposed to zoonotic diseases and blood borne pathogens.
• The noise level in the work environment is usually moderate.
• While performing the duties of this job, the Associate is regularly required to sit, stand, walk, use hands and fingers, reach with hands and arms, talk and hear, use computer keyboard, and view computer monitors. The Associate must occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required by this job include close vision, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination.
NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Auto-ApplyVet Tech - Large and Small Animal (NAMSA Talent Building Community)
Northwood, OH job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
Act with integrity in everything we do.
Provide best-in-class customer experiences.
Develop superior talent and deliver expertise.
Respond with agility and provide timely results.
Embrace collaboration, diverse perspectives and ideas.
Job Description:
• Performs dosing of test agents in small animals through a variety of dosing methods, including, but not limited to, intraperitoneal, intravenous, epicutaneous, intradermal, subcutaneous, intramuscular, and oral. Applies topical test agents as required.
• Performs scoring of test agents, assessing the subject's reaction to the agent.
• Performs post-procedure small animal euthanasia following established protocols.
• Performs and documents a variety of activities, including but not limited to, routine clinical observations, charting of physiological data and animal health status, taking study-required animal weights, etc.
• Assists with preparing animals for surgery and with administering and monitoring anesthesia during procedure and post-operatively. Performs incision monitoring, pain assessment and medication administration as needed post-procedurally.
• Performs intravenous and cardiac blood collection.
• Performs preventive health maintenance such as nail trims and bathing.
• Performs all aspects of veterinary directed care and general husbandry procedures according to established procedures, guidelines and study protocols that meet the acceptable criteria of the veterinarian. Administers medications as prescribed by veterinarian and/or protocol specifications.
• Communicates with Veterinarian and Study Director regarding living conditions and medical status of animals.
• Cleans and maintains routinely utilized equipment.
• Assists with other duties as assigned.
Qualifications & Technical Competencies:
• Certified Veterinary Technician (CVT) or ALAT certification is preferred.
• Bachelor's degree in scientific discipline or Associate of Science in Veterinary Technology required or equivalent through experience in lieu of education.
Working Conditions:
• While performing the duties of this job, the employee is regularly exposed to, and must handle and come in contact with, a variety of small laboratory animals. The employee is frequently exposed to sharps, wet conditions (non-weather), gasses such as CO2 and isoflurane, and toxic or caustic chemicals. The employee is occasionally required to work with radioactive isotopes and in a Bio-Safety-Level 2 (BSL2) environment and may, on rare occasion, be exposed to zoonotic diseases.
• The noise level in the work environment is usually moderate and occasionally loud
• While performing the duties of this job, the employee is regularly required to stand, walk, use hands, and talk or hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to sit, climb or balance, and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 20 pounds, and occasionally lift and/or move up to 75 pounds with assistance. The employee may be required to view computer monitors and stand for extended periods of time.
• Specific vision abilities required by this job include close vision, the ability to see a full range of colors, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination.
NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Auto-ApplyClinical Research Associate - NAMSA Future Openings USA
Northwood, OH job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
* Act with integrity in everything we do.
* Provide best-in-class customer experiences.
* Develop superior talent and deliver expertise.
* Respond with agility and provide timely results.
* Embrace collaboration, diverse perspectives and ideas.
Job Description:
* Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.
* Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
* May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.
* Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed.
* Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.
* Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
* Performs study-related training.
* Manages the development and maintenance of study documents, processes and systems as assigned.
* Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals.
* Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance.
* Attends internal and external meetings as required.
* Provides all job-related progress reports and visit documentation as required.
* May support safety activities such as narrative writing, managing the CEC/DSMB, etc.
* OUS: Prepares and coordinates submissions to regulatory authorities.
* May perform other activities as assigned.
Qualifications & Technical Competencies:
* Fluency in English and local language, if different, required.
* Higher education degree or equivalent education, training, and experience.
* Preferred 2 years clinical trial experience.
* Preferred monitoring experience.
* Able to work independently once trained.
* Good verbal and written communication skills.
* Strong organizational skills.
* Basic computer proficiency.
* Understanding of clinical research processes and regulations.
* Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required
Working Conditions:
* Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates.
* 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
* Extensive use of a computer keyboard.
Pay Range Minimum:
$54,400.00
Pay Range Target:
$80,100.00
Pay Frequency:
Annual
Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
NAMSA is an equal employment opportunity company.
NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Fair Chance Employment Statement:
At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history.
Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position:
* May operate equipment
* Records data timely and accurately
* May analyze and interpret data
* Conducts studies on medical devices that have an impact on human life
A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
Auto-ApplySenior Lab Technologist - In Vitro (Sign on Bonus Eligible)
Northwood, OH job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
Act with integrity in everything we do.
Provide best-in-class customer experiences.
Develop superior talent and deliver expertise.
Respond with agility and provide timely results.
Embrace collaboration, diverse perspectives and ideas.
Job Description:
• Executes routine testing per NAMSA SOPs, with appropriate data analysis (cytotoxicity, hemocompatibility and genotoxicity).
• Strictly adheres to GLP guidelines (good documentation, labeling and expiration of materials, participation in audits).
• Performs maintenance of cell lines through propagation, cell concentration and viability determination, and creation of plates used for standard testing.
• Performs the extraction process on prepared samples in accordance to ISO, USP and/or JMHLW regulations as directed by study protocol for biocompatibility assays.
• Communicates with clients in regards to particulate observations or article abnormalities. Routinely communicates with Study Directors and Quality Assurance about issues, results, or audits.
• Operates, cleans and maintains incubators, autoclaves, hoods, and other equipment routinely utilized.
• Performs preparation of media/reagents, maintains reagents and/or test article as required for testing, and maintains lab supplies/inventory.
• Performs data entry, routine calculations, analysis and interpretation of results, and routes all positive results or unusual testing occurrences to Management and/or the Study Director.
• May assist associates with performing routine test article/product preparation according to work instructions.
• Assist with creating and communicating schedules for the Associates appropriate for the lab workload. Provide any scheduling updates to NAMSA Associates or management as needed.
• Maintains ancillary records (logbooks, worksheets).
• May be required to perform personal gowning, environmental testing, and submit organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing.
• Adheres to established company processes.
• May provide administrative support.
• May prepare and maintain sterile glassware for the In-vitro lab and sample preparation process. Processes glassware through washer, autoclave and depyrogenation oven as needed.
• Completes chain of custody documentation for test article tracking.
• Responsible for daily monitoring of laboratory equipment, being on-call and responding to continuous monitoring alarms. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures.
• Assist with ordering and/or stocking supplies subject to approval
• May be certified as a trainer to provide Associates with on the job training. Documents training activities and completes certification of Associates. Trains Associates on Hemocompatibility and Cytotoxicity.
• Conduct routine studies independently. May be requested to conduct more involved custom studies.
• Participate in the creation and improvement of documents, test systems, quality systems, and workflow.
• May perform Environmental Monitoring, clean and disinfect cleanroom suites.
• Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management as required.
• May conduct genotoxicity testing.
• Other duties as assigned
Qualifications & Technical Competencies:
Working Conditions:
• While performing the duties of this job, the employee is regularly exposed to sharps, human and animal blood, and hazardous or caustic chemicals. The noise level in the work environment is usually moderate. Safety glasses and hearing protection are required in designated areas and when performing specific tasks.
• "While performing the duties of this job, the employee is regularly required to stand, walk, use hands, talk and hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to sit, climb or balance, and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 50 pounds, and occasionally lift and/or move up to 75 pounds with assistance. The employee may be required to view computer monitors and stand for extended periods of time.
• Specific vision abilities required by this job include close vision, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination"
NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Auto-ApplyLab Technologist - In Vivo
Northwood, OH job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
* Act with integrity in everything we do.
* Provide best-in-class customer experiences.
* Develop superior talent and deliver expertise.
* Respond with agility and provide timely results.
* Embrace collaboration, diverse perspectives and ideas.
Job Description:
* Prepare all testing/test article and animals according to written instructions and protocols.
* Review pour/decant data for accuracy.
* Execute routine testing per NAMSA SOPs, with appropriate data analysis.
* Communicate test schedule updates to NAMSA management as needed.
* Prepare and maintain reagents and/or test articles as required for testing.
* Maintain ancillary records (log books, worksheets).
* Maintain relevant supplies and equipment used in routine testing.
* Performs routine calculations, interprets results, and can route all positive results or unusual testing occurrences to management.
* Conduct daily health observations.
* Administer the test article or extract according to written instructions and protocols.
* May assist in the training of new associates.
* May be required to conduct necropsies.
* Provide suitable care for the welfare of the animals according to written instructions and protocols.
* Responsible for checking laboratory equipment.
* May be required to order laboratory supplies.
* May execute FDA ASCA testing per NAMSA SOPs
* Interact with client/regulatory auditors.
Qualifications & Technical Competencies:
Principal Duties and Responsibilities
* May prepare all testing/test article and animals according to written instructions and
protocols.
* May execute routine testing per NAMSA SOPs, with appropriate data analysis.
* May communicate test schedule updates to NAMSA management as needed.
* May prepare and maintain reagents and/or test articles as required for testing.
* Maintain ancillary records (log books, worksheets).
* Maintain relevant supplies and equipment used in routine testing.
* Routes all positive results or unusual testing occurrences to management.
* May be required to conduct daily health observations.
* May be required to administer the test article or extract according to written instructions
and protocols.
* May be required to conduct necropsies.
* May be required to provide suitable care for the welfare of the animals according to written
instructions and protocols.
* May be responsible for checking laboratory equipment, being on-call and respond to continuous
monitoring alarms. If needed, the Associate will respond in accordance with criteria outlined in
Standard Operating Procedures.
Qualifications and Skills
Bachelor's degree in scientific discipline or a high school diploma with at least 3 years of
relevant laboratory experience.
Technical Competencies
* Awareness of applicable guidelines and regulations appropriate for primary department, these
may include USDA, USP, Tripartite, FHSA, CTFA, FSA, ICH, EP, and/or JP.
* Knowledge of metric system, scientific applications, experimental design, and data evaluation.
* Ability to work in a GLP/GMP environment.
* Working knowledge of applicable NAMSA systems (LIMS, Trackwise, MasterControl, etc.) as
appropriate per primary department.
Working Conditions
* Physical activities include standing, walking, sitting, using hands to finger, handle, or
feel, and reaching with hands and arms. Occasionally required to climb or balance.
* Vision abilities required include close vision, color vision, depth perception, and ability to
adjust focus.
* Physical requirements include frequently lifting up to 25 pounds or more on occasion.
* Employee must be able to talk and hear.
Working Conditions:
* Physical activities include walking, sitting and standing for prolonged periods.
* Extensive use of computer keyboard and mouse.
* Vision abilities include close vision, color vision, depth perception, and ability to adjust focus.
* Physical requirements include frequently lifting up to 25 pounds or more and to climb a four foot ladder if necessary.
* Must be able to talk and hear.
NAMSA is an equal employment opportunity company.
NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Auto-ApplySenior Lab Technologist-In Vitro (Sign on Bonus Eligible)
Northwood, OH job
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
* Act with integrity in everything we do.
* Provide best-in-class customer experiences.
* Develop superior talent and deliver expertise.
* Respond with agility and provide timely results.
* Embrace collaboration, diverse perspectives and ideas.
Job Description:
* Executes routine testing per NAMSA SOPs, with appropriate data analysis (cytotoxicity, hemocompatibility and genotoxicity).
* Strictly adheres to GLP guidelines (good documentation, labeling and expiration of materials, participation in audits).
* Performs maintenance of cell lines through propagation, cell concentration and viability determination, and creation of plates used for standard testing.
* Performs the extraction process on prepared samples in accordance to ISO, USP and/or JMHLW regulations as directed by study protocol for biocompatibility assays.
* Communicates with clients in regards to particulate observations or article abnormalities. Routinely communicates with Study Directors and Quality Assurance about issues, results, or audits.
* Operates, cleans and maintains incubators, autoclaves, hoods, and other equipment routinely utilized.
* Performs preparation of media/reagents, maintains reagents and/or test article as required for testing, and maintains lab supplies/inventory.
* Performs data entry, routine calculations, analysis and interpretation of results, and routes all positive results or unusual testing occurrences to Management and/or the Study Director.
* May assist associates with performing routine test article/product preparation according to work instructions.
* Assist with creating and communicating schedules for the Associates appropriate for the lab workload. Provide any scheduling updates to NAMSA Associates or management as needed.
* Maintains ancillary records (logbooks, worksheets).
* May be required to perform personal gowning, environmental testing, and submit organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing.
* Adheres to established company processes.
* May provide administrative support.
* May prepare and maintain sterile glassware for the In-vitro lab and sample preparation process. Processes glassware through washer, autoclave and depyrogenation oven as needed.
* Completes chain of custody documentation for test article tracking.
* Responsible for daily monitoring of laboratory equipment, being on-call and responding to continuous monitoring alarms. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures.
* Assist with ordering and/or stocking supplies subject to approval
* May be certified as a trainer to provide Associates with on the job training. Documents training activities and completes certification of Associates. Trains Associates on Hemocompatibility and Cytotoxicity.
* Conduct routine studies independently. May be requested to conduct more involved custom studies.
* Participate in the creation and improvement of documents, test systems, quality systems, and workflow.
* May perform Environmental Monitoring, clean and disinfect cleanroom suites.
* Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management as required.
* May conduct genotoxicity testing.
* Other duties as assigned
Qualifications & Technical Competencies:
Principal Duties and Responsibilities
* May perform routine test article/product preparation according to work instructions.
* May execute routine testing per NAMSA SOPs, with appropriate data analysis.
* Performs routine calculations, interprets results, and can route all positive results or unusual testing occurrences to Management.
* May provide on the job training.
* Assure testing/test article preparation is performed within due dates.
* May prepare and maintain cell lines and reagents required for testing, as applicable for primary department.
* Ensures all testing/test article preparation is conducted according to the written instructions.
* Maintain ancillary records (logbooks, worksheets).
* Conduct routine studies fully independently.
* Is routinely involved with the conduct of more involved in both study design and execution of more complex studies, as required by primary department.
* Participate in the development and improvement of documents, test systems, quality systems, and workflow.
* Conducts genotoxicity testing.
* May be responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms. If needed, the associate will respond in accordance with criteria outlined in Standard Operating Procedures.
* May order and/or stock supplies subject to approval.
* May perform environmental monitoring and trend data.
* May review reagent preparation worksheets, raw data, and documentation as applicable per primary department.
* May be required to operate autoclave.
Qualifications and Skills
* Bachelor's degree in scientific discipline appropriate for hiring department and at least three years of related laboratory experience.
Technical Competencies
* Awareness of applicable guidelines and regulations appropriate for primary department, these may include USP, ISO, CTFA, FSA, ICH, EP, and/or JP.
* Knowledge of metric system, scientific applications, experimental design, and data evaluation.
* Can write technical documents and communications (SOPs, protocols, Trackwise records) with minimal management input.
* Proficient at applicable NAMSA systems (LIMS, Trackwise, MasterControl, etc.) as appropriate per primary department.
* Ability to work in GMP/GLP environment.
Working Conditions
* Physical activities include standing, walking, sitting, using hands to finger, handle, or feel, and reaching with hands and arms. Occasionally required to climb or balance.
* Vision abilities required include close vision, color vision, depth perception, and ability to adjust focus.
* Physical requirements include frequently lifting up to 25 pounds or more on occasion.
* Employee must be able to talk and hear.
Working Conditions:
* While performing the duties of this job, the employee is regularly exposed to sharps, human and animal blood, and hazardous or caustic chemicals. The noise level in the work environment is usually moderate. Safety glasses and hearing protection are required in designated areas and when performing specific tasks.
* "While performing the duties of this job, the employee is regularly required to stand, walk, use hands, talk and hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to sit, climb or balance, and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 50 pounds, and occasionally lift and/or move up to 75 pounds with assistance. The employee may be required to view computer monitors and stand for extended periods of time.
* Specific vision abilities required by this job include close vision, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination"
NAMSA is an equal employment opportunity company.
NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Auto-Apply