Sr. Microbiologist III

3 days left

Employer
Integrated Resources
Location
Morris Plains, New Jersey, US
Salary
Competitive
Posted
Jun 10, 2021
Closes
Jun 16, 2021
Ref
2240186293
Discipline
Other
Employment Type
Full time
Salary Type
Salary
Job Description
Actual Title: ** Sr. Microbiologist III **Location: Morris Plains, NJ (must be local candidate)*** Minimum experience and EDU: Bachelors and 4 years, or equivalent combination ***The Senior Microbiologist will be responsible to perform high throughput laboratory work to meet production schedules and project milestones. They are expected to follow procedures and sampling and testing as needed. They are also responsible to perform trending, review and assessment of environmental monitoring, microbiological testing of pharmaceutical grade water, in-process materials, test methods verifications/validations and development and equipment evaluation and qualification in compliance with SOPs, cGMP, USP, and EU regulations by all personnel. Microbiological disciplines common to the laboratory include, but are not limited to:ESSENTIAL JOB FUNCTIONS* (PRIMARY RESPONSIBILITIES): Environmental monitoring, Water Sampling, Bioburden Testing and Endotoxin Testing Performs critical records documentation and reviews and participates in documentation preparation and assists with regulatory audit review. Reviews and approves environmental monitoring data, escalates issues to management as needed. Notifies laboratory management when unusual results or data deviations occur. Composes investigations as it pertains to microbial testing and results. Writes technical protocols and reports of microbiological tests and studies. Researches and recommends new technologies. Writes, updates, and evaluates test methods and SOPs. Utilizes technical skills to lead or perform in-depth investigations into out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence. General knowledge of USP, EP and ISO guidelines as they pertain to microbiological quality. Complies with and implements safety standards. Participates in internal/external audits. Represents department on project and cross-functional teams and committees when needed. Builds productive working relationships. Escalates issues to manager for resolution, as deemed necessary. Assists with various projects as assigned by laboratory management. Proficient in methods and techniques used for bioburden, environmental monitoring, biological indicator, endotoxin testing, sterility testing, growth promotion testing and other miscellaneous microbiological testing. Maintains accurate, detailed records of work performed. Tracks microbiological testing results. Assists in assessing the impact of trending results.CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES): Detailed working knowledge of current standards and procedures for facilities environmental monitoring and in-process test methods. Experience with development, qualification and implementation of microbial methods. Expertise with current guidance and regulatory expectations; proven problem-solving abilities, excellent oral and written communication skills, and strong interpersonal skills are required. Must possess excellent communication (oral and written), organizational, interpersonal, and leadership skills. Must be able to directly lead and/or coordinate high impact process improvement projects. Must have the ability to manage multiple projects. Must be proficient with MS Office applications.EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL) Bachelors degree in microbiology, biology, or other relevant scientific discipline and a minimum of 4 years related lab experience; or equivalent combination of education and experience. Strong background in facilities EM / microbiological control and expertise with microbial techniques, interpretation of results during investigations and detection of microbial trends. Must possess proven understanding of SOPs, cGMP and GLPs guidelines and regulations.PHYSICAL REQUIREMENTS AND WORKING CONDITIONS Environment: Be able to work in GMP lab areas as well as Manufacturing and R&D environments. Potential exposure to extreme temperature with water sampling. Repetitive motions are involved. Physical: Be able to lift up to 25 lbs. and climb ladders for sampling tasks. Must be able to pass gowning qualification. Equipment Used: Office Equipment Laboratory and/or Related Equipment (e.g., instrumentation, fume hoods, incubators, freezers) Vision: See in the normal visual range with or without correction; vision sufficient to read computer screens and printed documents. Hearing: Hear in the normal audio range with or without correction.Job SnapshotEmployee Type:Full-TimeLocation:Morris Plains, NJJob Type:OtherExperience:Not SpecifiedDate Posted:5/26/2021

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