Director – Microbiology

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Position Title:	Director, Microbiology	Department:	Microbiology
Reports To:		Work Location:	Decatur, Illinois

Position Summary:

The Microbiology Director ensures that all microbiological and environmental monitoring requirements are in compliance with cGMP standards, Food and Drug Administration (FDA), European Pharmacopoeia (EP), United States Pharmacopoeia (USP), AMMI, and ISO guidelines. Directs the organization standards as they apply to the department. Directs and oversees the compliance of the department and organization for internal product line and third-party customer line. Interacts with the customer and Agency officials during routine and nonroutine site inspections. Oversees that the staff is trained, troubleshoots microbiological testing problems, development and implementation of departmental procedures are conducted in accordance with SOP’s and methods and ensure SOP’s and Method’s meet Company and FDA standards.

Essential Duties and Responsibilities:

• Directs the supervision of all microbiological and environmental tests that are performed and reported in compliance with cGMP standards and in a timely manner.

• Overview, conducts, and/or delegates the final review and approval of environmental and microbiological test results including contract labs requirements before the documentation are forwarded to QA Batch Record reviewers.

• Oversee the review of compliance guidelines, industry trends, customer’s projects, validation efforts, and development efforts to ensure Microbiology/Environmental departments meet or exceed the minimum requirements.

• Represent the department and company in all Regulatory and customer audits.

• Oversee the timely completion of projects, CAPAs, and investigations.

• Oversee and assures that the departmental training program meets Company standards.

• Oversee and review responses compliance audits/deficiencies and CAPA plans of areas of responsibility.

• Oversee the coordination of development and validation of microbiological methods.

• Perform employee performance appraisals in a timely

• Oversee and conducts the hiring process of new personnel for the Microbiology and/or Environmental departments (Salary and Hourly).

• Oversee and/or ensures that all laboratory equipment are in compliance with company and regulatory

• Drives in conjunction with other departments and Rising sites the global application of compliance and operation.

Additional Responsibilities:

• Directly supervises the Microbiology and Environmental Monitoring Supervisors. Carries out management responsibilities in accordance with the organization’s policies and applicable laws. Planning, assigning, and directing work, appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Review of new and revised regulatory and guidance documents and processes/practices to assure continuous improvement and compliance.

Education and Experience:

• Bachelor’s Degree in Microbiology and seven years of experience in a Pharmaceutical Microbiology Laboratory under cGMP guidelines. Minimum of three years of management experience preferred. Experience should include exposure and understanding in the following areas: FDA, EP, ISO, AMMI regulations, current LISP and Supplement in Microbiological and Environmental requirements, Isolation and identification of Microbial Isolates, Aseptic Techniques, Gowning Techniques, Bioburden Test by MPN, Plate Count, and Membrane Filtration methods, Culture Maintenance and Record Maintenance, BF/Sterility testing, AET, BRT, and Environmental Monitoring Guidelines for Viable and Non-Viable Monitoring. An equivalent combination of education and experience may substitute.

Job Prerequisites:

• Ability to meet attendance standards. All full-time employees are required to work a minimum 40-hour week. At times it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines.

• This individual must have an understanding of regulatory guidelines and/or compliance documents.

Physical Demands, Mental requirements, and Work Environment:

• While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use.

Mental Requirements:

• Ability to hear accurately the spoken word with moderate office and plant noise;

• Ability to apply deductive reasoning and understand complicated issues;

• Ability to receive instructions and follow work rules and company policies;

• Ability to follow safety and security practices;

• Ability to meet deadlines and effectively deal with office stress;

• Ability to accurately communicate ideas, facts and technical information; and

• Maintain confidentiality of certain information.

Disclaimer:

• The list under Essential Functions and Additional Responsibilities is not exhaustive, but merely the most accurate list for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change. This position description in no way states or implies that the responsibilities and tasks are the only responsibilities and tasks to be performed by the employee occupying this position. She/He will be required to follow any other instructions and to perform any other job-related duties as required by his/her supervisor/manager. Requirements stated are minimum levels of knowledge, skills and/or abilities to qualify for this position. To perform the duties and responsibilities of this position successfully, employee will possess the abilities and aptitudes to perform each task proficiently. Employment decisions, including promotions, transfers and others, are based on meeting all requirements and on organizational needs, the employee being in good standing (including lack of disciplinary actions), meeting all applicable performance standards and other non-discriminatory criteria. The methods of fulfilling requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.

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Director – Microbiology

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