MICROBIOLOGY MANAGER - BILINGUAL

Supervises AQ operations in the area of Automatic Liquid Processes in Nogales, Sonora, including but not limited to validation activities, preventive and corrective action activities, quality assessment and inspection, compliance with CFR and other regulatory requirements, establishing Good laboratory practices and handling of aseptic process exceptions; Management of internal and external audits in the ALP process and other related activities

Supervises sampling, testing and control of products, materials and processes for compliance to establish quality microbiological standards, in the state of raw material and / or after several states of manufacture.
Supervises the use of various kinds of equipment tests and the application of standardized test methods. Provides leadership, advice, feedback and guidance to subordinates
Key functions of this position include: industrial microbiology, consulting, auditing, training, development of test standards in compliance with professional and industrial standards and good laboratory practices and management of environmental control practices and tests for 3 plants of Manufacturing (2 in Nogales and 1 in Magdalena, Sonora.)
Typical responsibilities could include:
Provide guidance, dexterity or support to team members, business unit, and support organizations.
O Conduct or coordinate microbiological tests and verify that tests are conducted based on recognized standards.
O Analyze data and conduct spec research, formulate recommendations and provide professional reports.
O Evaluate the status of compliance and take appropriate preventive and corrective actions.
O Maintain work knowledge in the applicable disciplines.
O Influence and directs others toward the desired goals.
O Train, advise team members on career development and project / team objectives.
O Make decisions with business sense, deliver results and respond in a way that supports the team and individual credibility.
O Effective communication with internal and external shareholders to achieve desired results.
Management of all quality operations for the A.L.P.
Including but not limited to: quality inspections, process validation evaluation, environmental management and Good Manufacturing Practices, handling of nonconformities, CAPA, internal audits and exception reporting, handling of external audits and ensuring compliance with FDA, ISO and other regulations of other countries.
Management of the following environmental control practices for 2 plants in Nogales and 1 plant in Magdalena, Sonora.):
O Administer laboratory equipment for Microbiology / Quality responsible for the product, microbiological tests, environmental monitoring of controlled manufacturing areas and bioburden programs for product family. Ensure that the members of your team are properly trained and your required documentation is complete, recorded and updated.
O Administer bioburden (biological loads) and audit dose programs to ensure compliance with the standards specified in ANSI / AAMI / ISO.
O Coordinate manufacturing activities with the sterilization and health care assurance team to support new, revised and sterilized products.
O Develop, execute and maintain validations for environmental controls, cleaning and sanitation.
Evaluates results of the pest control system or problems in Nogales and Magdalena.
O Provides leadership in conducting environmental monitoring and sampling of products for laboratory testing. Analyze trends and document all results.
O Manages the control of changes that impact the environmental controls and sterilization assurance.
O Coordinates the interface between key suppliers, purchases and manufacturing equipment to provide adequate and acceptable supplies of raw materials. Executes audit to suppliers as required in the area of microbiology.
Communicates fully with superiors, subordinates and others with whom they need to know.
It contributes to creating a work environment in which all team members are respected without regard to their individual differences and motivates them to improve their individual and team contributions to achieve the desired results of the business.
Establishes and maintains internal controls within its area of responsibility in compliance with applicable standard operating procedures, good manufacturing practices and Corporate Financial Instructions.
Maintains direct compliance with FDA and ISO in the regulations within its area of responsibility.

ENGLISH: Bilingual
EXPERIENCE: 7-10 years of experience in supervising positions in medical products or pharmaceutical industries regulated by US, Canada, Japan or European.
Evidence of a solidified specialized knowledge, expertise in the field of your specialty, providing and providing a working record within a variety of clients related to the required business and functions.
Knowledge of CFR 820, 210, 211, PAL, Canadian Regulations and ISO standards strongly desired.
Critical skills required for position:
Oral communication
Decision making
Employee Development
Motivation
Collaboration
Influence
Cognitive power
Business Intuition
Results Oriented
Reliability