The Microbiologist will provide technical support to group members and support to management as pertaining to the respective responsibilities.
Performs functions such as executing laboratory testing and data analysis, test method development, stability, validation development and implementation, and environmental monitoring.
This position is responsible for the development, implementation, and monitoring of medical and skin products in compliance with all applicable corporate and regulatory policies.
- 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.
- Submit samples for shipment to third party labs when necessary
- Manage sample/testing processing with third party labs, ensure timely testing and result reporting.
- Maintain GMP/GLP laboratory notebooks and documentation relevant to the duties and responsibilities assigned.
- Maintain laboratory instrumentation required for testing.
- Assist in the review of test data and report any deviations to supervisor.
- Assist with proper execution of laboratory 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.
- Design experimental plans to address specific laboratory issues as needed.
- Assist management in writing/updating Standard Operating Procedures (SOPs).
- Participate in projects involving the Quality Control and/or Microbiology departments, including new method/equipment validations.
- Train team members in microbiology.
- Provide gowning training and qualification to operators, cleaning and other essential staff.
- Provide microbiological support to the facility.
- Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures.
- Perform other related duties as required.
Bachelor’s degree, in Microbiology or Biology preferred
3 – 5 years of relevant GMP/GLP laboratory experience in regulated industry preferred
Capable of both written and verbal effective communications skills including presentations
Must be able to work independently with minimal supervision
Knowledge of MS Office Suite
We are committed to creating an environment where all employees are valued and respected. We offer a competitive benefits package including 401(K) savings plan with match, medical, vision, dental, life insurance, tuition reimbursement, and employee stock purchase plan.
To find out more about our company, visit our website at:
No Agencies. LOCAL CANDIDATES ONLY PLEASE. EOE, M/F, D/V
Integra is not currently accepting unsolicited assistance or resumes from search firms for this employment opportunity. All resumes submitted by search firms or agencies to Integra or its employees, agents, directors or representatives in any form or method without a valid written agreement covering this position will be deemed the sole property of Integra. No fee shall be paid in the event the candidate is hired by Integra as a result of the referral or through other means.
Search firms are essential to the recruitment and staffing efforts at Integra and we value the partnerships we have built with our preferred vendors. For this reason, Integra has established and regularly maintains a vendor list. Please note that even preferred vendors are required to have a written search agreement signed by an authorized signatory of Integra in order for a fee to be paid for any candidate referrals.
Amount of Travel
Work At Home
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