Plastikon Healthcare is looking for a Microbiology Manager who will manage and monitor day-to-day activities relating to the environmental quality processes and practices at the site applicable to the company’s regulatory and statutory requirements. This position provides technical support and leadership as the Environmental Quality SME by developing, validating, coordinating, and trending routine and special testing of environmental monitoring, sterility, endotoxin, and particulates. The position requires experience in the development of facility environmental monitoring and personnel monitoring programs. The incumbent will support pharmaceutical and medical device manufacturing operations under the direction of the Quality Director. The incumbent is responsible to follow company policies, cGMP’s, and all Standard Operating Procedures as mandated for this position.
Job Description:
- Provide technical knowledge and leadership for sterilization processes in conjunction with support in resolution of plant challenges, method development and project work.
- Establish and manage testing schedules for timely release of products and materials in alignment with the business goals and priorities.
- Provide oversight and technical knowledge to ensure the pharmaceutical site cleaning and disinfection program is adequate to ensure control of the cleanroom environment to applicable company, regulatory and statutory requirements.
- Act as the site EQ technical lead for internal / external stakeholders, regulatory inspections and / or any other business requirements.
- Establish and maintain certification procedures for test methods and for testing personnel.
- Support activities as assigned by Quality Leadership to facilitate testing, qualification, system improvements and compliance [Change Controls, CAPA, Out of Specification (OOS), Validation documents, Laboratory Investigations, Standard Operating Procedures].
- Provide oversight and technical knowledge to ensure proper microbiological monitoring of plant utility systems, including routine trend analysis.
- Provide oversight and technical knowledge in developing solutions to environmental, particulate, microbial, and sterilization challenges for the site and the QC Lab.
- Maintains safe and healthy work environment by following standards and procedures and complying with legal regulations.
- Operate in compliance of cGMP, 21CFR and USP regulatory requirements.
- Other duties as assigned.
ESSENTIAL FUNCTIONS
Reasonable Accommodations Statement
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
POSITION QUALIFICATIONS
- A minimum of 10 years’ experience in a pharmaceutical quality control role, operating in an FDA regulated GMP environment.
- A minimum of 5 years supervisory / management experience is required.
- Flexibility and ability to manage multiple and competing priorities.
- Ability to multi-task with strong sense of urgency; ability to meet deadlines.
- Self-motivated, dependable, well organized, and able to communicate effectively and efficiently, both orally and in writing.
- Must hold excellent problem-solving skills.
- Excellent attention to detail and capable of performing dependable, accurate work.
- Bachelor’s degree from an accredited college or university in microbiology or related science field.
LANGUAGE SKILLS
Required reading, writing, and speaking fluently in English.
PHYSICAL DEMANDS
While performing the responsibilities of the job, the employee is required to talk and listen. The employee is required to sit, stand, walk, reach with arms and hands, lift objects, and use their hands and fingers to handle or feel. The employee is occasionally required to climb or balance, stoop, and kneel, crouch or crawl. Visions abilities required by the job include close vision. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
