Microbiology Manager - Nogales, United States - Avanos Medical

Description

JOB POSITION PURPOSE/ACCOUNTABILITIES

Provides leadership of the microbiology laboratory ensuring compliance with quality procedures and processes. Responsible for supervising laboratory personnel as well as performing test procedures in a laboratory environment to ensure quality.

They generally consist of making measurements, performing various routine quantitative and qualitative analytical tests, performing calculations and determinations in the tests, and evaluating the physical-chemical characteristics.

Analyzes the results of tests and experiments to ensure compliance with physical and/or chemical specifications.


RESPONSABILITIES:
Manage the Microbiology/Quality laboratory team responsible for the product, microbiological tests, environmental monitoring of controlled manufacturing areas and bioburden programs (biological loads) for product families

Ensures that team members are trained in laboratory methods

Review laboratory documentation according to good documentation practices

Lead validation projects for new instruments, methods, and equipment

Provides support as required in plant projects (new equipment/modifications) to avoid environmental impacts

In charge of the laboratory purchases by working closely with buyers

Provides support as required by the EM programs of the N1, N2 and Magdalena plants

Responsible for carrying out the Biodurden program of the product

Responsible for complying with the Water Tests. Identifying sampling locations, creation of the sampling plan and data analysis

Responsible for biocontamination assessments and control plans

Responsible for the pest control program

Supervises good laboratory practices, GPM's and GDP's

Provides leadership during OOS lab investigations and follow-up on the implementation of corrective and preventive actions.

Makes business-sense decisions, delivers results, and responds in a way that supports team and individual credibility.

Administration of all quality operations for the A.L.P. process.


including, but not limited to:

quality inspections, process validation evaluation, environmental management and Good Manufacturing Practices, non-conformity management, CAPA, internal audits and exception reporting, external audit management and ensuring FDA compliance , ISO and other regulations of other countries.

Prepares reports for management.

Maintains all the documentation to ensure data accessibility and protection of information ownership.

Continuously works to improve all the systems under his responsibility.

Report dangers and injuries to the Leader and/or Immediate Supervisor.

Comply with the safety and hygiene rules and environmental policy.

Attend the trainings that are scheduled by the company.

Responsible for executing regulatory requirements according to the quality manual


REQUIRED CALIFICATIONS:

Education:
University degree related to job description.


English:
Intermedium


Experience:
Minimum 4 years.


Preferred Qualifications:
Biological / Microbiology / Biochemical

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