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The Microbiology Technician I will provide support to the QC Microbiology Laboratory as pertaining to the respective responsibilities. Performs functions such as executing laboratory testing for in-process and finished good products, water, stability studies, and validation studies as well as performs environmental monitoring. This position is responsible for operating in compliance with all applicable procedures and policies
This is a second shift role. Work schedule aligned to this shift is: Monday to Thursday 4:00pm- 2:30am.
*Training will take place on first shift Monday-Friday 8:00am-4:30pm.*
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Ensure compliance with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR and the Medical Device Directive.
- Perform and document in-house microbiological testing on all in-process and finished products to comply with acceptance requirements.
- Perform LAL, water analysis, growth promotion, gram staining, identification of microorganisms and other microbiological testing
- Perform and document environmental monitoring in compliance with Standard Operating Procedures.
- Report any equipment and testing deviations to the Supervisor
- Submit samples for shipment to third party labs when necessary
- Maintain GMP/GLP laboratory notebooks and documentation relevant to the duties and responsibilities assigned.
- Maintain laboratory instrumentation required for testing.
- Assist with proper execution of laboratory Alert/Action (AA) and Out-of-Specification (OOS) investigations.
- Interact and coordinate activities with other departments and external vendors to support and meet the facility goals and objectives, especially related to environmental monitoring.
- Assist management in updating Standard Operating Procedures (SOPs).
- Perform data entry and assist with trend reporting as needed.
- Train team members in Microbiology department.
- Provide gowning training and qualification to operators, cleaning and other essential staff.
- Handle and dispose of bio-hazard material in compliance with OSHA and Standard Operating Procedures.
- Perform other related duties as required.
REQUIREMENTS
- Bachelor’s degree, in Microbiology or Biology preferred
- 0-3 years of relevant GMP/GLP laboratory experience in regulated industry preferred
- Capable of effective written and verbal communication
- Must be able to work independently with minimal supervision
- Knowledge of MS Office Suite
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law
| EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the
ADA
. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
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