Principal Lab Tech In Vitro

North American Science Associates, Inc.; Northwood (OH); On-site; USD 55,000 - 85,000; Full time

Job summary

You will communicate with clients and study directors, organize schedules, manage reagents, and ensure proper documentation and chain-of-custody. This role demands meticulous data handling in a GMP/GLP environment and regular equipment maintenance.

Qualifications

• Bachelor’s degree in scientific discipline with at least two years of lab experience.
• Three years’ experience in a laboratory setting, preferably in a GLP environment.
• Experience following GMP/GLP guidelines and applicable regulations.

Responsibilities

• Strictly adheres to GLP guidelines and conducts audits.
• Performs routine testing per NAMSA SOPs with data analysis.
• Maintains cell lines, propagation, viability, and plate preparation.
• Executes ISO 10993, USP, and JMHLW compliant extraction processes.
• Communicates with clients regarding observations or article abnormalities.
• Routinely communicates with Study Directors and QA about issues, results, or audits.
• Creates, communicates and implements schedules for Associates for lab workload.
• Performs data entry, calculations, analysis and routes results for review.
• Prepares and maintains reagents/test articles and sterile glassware.
• Maintains ancillary records and equipment, and monitors lab environment.

Skills

GLP compliance

Cytotoxicity

Hemocompatibility

Genotoxicity

Technical writing

Education

Bachelor’s degree in scientific discipline

High school diploma with 6+ years lab experience

Tools

LIMS

TrackWise

MasterControl

Job description

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 theMission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our coreValues: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:_Qualifications & Technical Competencies:Principal Duties and Responsibilities• Strictly adheres to GLP guidelines (good documentation, labeling and expiration of materials, participation in audits).• Executes routine testing per NAMSA SOPs, with appropriate data analysis (cytotoxicity, hemocompatibility, and genotoxicity).• 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 10993, 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. • Responsible for creating, communicating and implementing schedules for the Associates appropriate for the lab workload. Provide any scheduling updates to NAMSA Associates or management as needed.• 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.• Prepares and maintain reagents and/or test articles as required for testing.• 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.• Operates, cleans and maintains incubators, autoclaves, hoods, and other equipment routinely utilized.• Performs preparation of media/reagents and maintains lab supplies.• 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.• May assist Associates with performing routine test article/product preparation according to work instructions.• Manage inventory within the lab. Order and/or stock supplies subject to approval• Certified as a trainer to provide on the job training for new or current Associates. Organizes, coordinates, and documents training activities, completes certification, and assesses yearly competency of Associates. Trains Associates on all assays types(Hemocompatibility, Cytotoxicity and Genotoxicity).• Conduct routine studies fully independently. May be requested to conduct more involved custom studies.• May perform Environmental Monitoring, clean and disinfect cleanroom suites.• May communicate with clients as needed to confirm documentation on receipt paperwork is accurate and complete.• Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management as required.• Conducts genotoxicity testing (AMES, Chromosomal Aberration Study, Mouse Lymphoma Assay).• Is routinely involved in both creation of study design and execution of more complex studies, as required by primary department.Qualifications and SkillsBachelor’s degree in scientific discipline appropriate for hiring department and at least two years of related laboratory experience, or a high school diploma with at least 6 years of relevant laboratory experience.Three years’ experience in a laboratory setting required, preferably in a GLP environment.Technical CompetenciesAwareness 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 draft technical documents and communications (SOPs, protocols, Trackwise records).Proficient at applicable NAMSA systems (LIMS, Trackwise, MasterControl, etc.) as appropriate per primary department.Ability to work in GMP/GLP environment.Working ConditionsPhysical 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 coordinationNAMSA is an equal employment opportunity company.NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.