Our primary mission is to provide the highest quality orthopaedic implants to restore, repair and regenerate the biological and mechanical functionality that has been lost as a result of degenerative disease and/or trauma related incidents.
This position will support the design, execution and interpretation of process development and validation studies as well as ongoing microbial strategic initiatives that advance and expand the corporate service portfolio. The incumbent will lead or assist in the completion and execution of scientific studies, which address the needs of the Company’s ongoing laboratory, quality, and operations activities with focus on microbiological testing, method development, validation, process improvements and optimization. The incumbent will also lead and support all validation activities including equipment, process and product related validations. Produce qualification protocols, execute activities and prepare reports for all validation activities to internal and industry standards. In addition, the incumbent will possess a strong quality background, which will aid in the identification, investigation, and resolution of company-wide process improvements.
Reasonable Accommodations Statement
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
· Suggest and implement process improvements that comply with established quality standards and operational metrics.
· Establish sampling plans and statistical rational for acceptance or rejection of acceptance criteria and/or investigational hypotheses.
· Assist in the design and creation of validation protocols, creation of acceptance criteria, data analysis and reports.
· Oversee microbiology, including analyzing the effects of process changes (antimicrobial agents, chemical reagents, etc.) on the various aerobic, anaerobic and fungal challenge microorganisms.
· Perform equipment qualification and calibration activities and/or coordinate outsourced activities.
· Execute bioburden reduction process development and validation activities.
· Operate various laboratory equipment for the completion of cleaning, validations, routine maintenance and calibrations for use in manufacturing.
· Communicates project status to superiors as appropriate.
· Recommends alternatives when problems arise during life of projects.
· Fundamental knowledge of aseptic laboratory techniques and principals as they relate to industrial USP microbiology (e.g. microbial growth, isolation and identification, final product and raw material sterility testing, bioburden testing, bacteriostasis/fungistasis testing, exhaustive rinse, process challenge/spiking testing, antibiotic efficacy testing, etc.).
· Follow protocols, record data as per cGLP/cGMP guidelines, organize and analyze raw data using common statistical functions and summarize the results in a final written report.
The incumbent must be confident with quality control, design control, validation and document control paperwork procedures and have the ability to communicate clearly in written and verbal methods. All work is to be completed in accordance with regulatory and quality standards for medical device, biologic and/or pharmaceutical laboratories.
- Superior technical writing skills and statistical data analysis and interpretation capabilities.
· Reliable, organized and methodical in work ethic.
· Promote the organization, its vision and reinforce brand awareness and visibility.
· Represent the organization at events, functions, society and conference meetings.
· Motivate team members through strong leadership and effective communication.
- The ability to be a self-starter and function independently.
- The ability to adapt and be flexible to changing needs and responsibilities.
- The ability to function independently with minimal supervision in addition to working well in a group environment.
· Dynamic, fast paced, start-up environment.
· Relentless focus on execution, accountability, quality and delivery schedule.
· Team-oriented, transparent, open communication, growing and forward moving.
Education: B.S. in biological sciences (e.g. Microbiology, Chemistry, Biology or engineering related field) required. A graduate degree in a scientific discipline is a plus.
- Must possess a minimum of 3-8 years in an industrial quality, validation and/or laboratory setting (i.e. allograft, medical device, pharmaceutical, or biologics company).
· Previous experience working with allograft products is strongly preferred.
- Solid understanding of quality control microbiology techniques and procedures (e.g. microbial growth, isolation and identification, product and raw material sterility testing, bioburden testing, environmental testing, bacteriostasis/fungistasis testing).
· Superior technical writing skills and statistical data analysis capabilities.
· Solid grasp of cGLP, cGMP, USP and/or ISO guidelines and methodologies as appropriate.
· Detail orientated and excellent aseptic technique is a must.
· Experience with handling biohazardous material (human, biological and chemical samples).
· Experience with equipment/method/process validation design and acceptance criteria
· Knowledge of basic sterilization practices using gamma or electron beam radiation is a plus.
· Equipment and method validation knowledge and experience.
· Knowledge of aseptic techniques for common laboratory procedures (e.g. sterility testing, bioburden analysis etc.).
· Experience with handling biohazardous material (human and microbial samples).
· Strong computer skills with MS Excel, Word and statistical graphing packages.
· Strong qualitative and quantitative analysis skills.
· Development, optimization and validation of laboratory test methods.
· Project management experience is a plus.
Job Type: Full-time
Salary: $70,000.00 /year
- process engineering: 5 years (Required)
- Industrial Quality: 3 years (Required)
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off
This Company Describes Its Culture as:
- Detail-oriented -- quality and precision-focused
- Innovative -- innovative and risk-taking
- Outcome-oriented -- results-focused with strong performance culture
- Monday to Friday
- Day shift