Manager, Microbiology Position Available In Broward, Florida

Manager, Microbiology Aveva Drug Delivery Systems Inc – 3.7 Tamarac, FL Job Details Full-time $110,000 – $135,000 a year 22 hours ago Qualifications Microsoft Word Statistical software CGMP Microbiology Microsoft Excel Microsoft Access Management 5 years Laboratory experience English GMP Microbiology Project management Bachelor’s degree Regression analysis Senior level Communication skills FDA regulations Time management

Full Job Description Job Summary:

The Manager, Microbiology ensures that all microbiological and environmental monitoring requirements are in compliance with cGMP standards, Food and Drug Administration (FDA), European Pharmacopeia (EP), United States Pharmacopeia (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 the staff is trained, troubleshoots microbiological test problems, development and implementation of departmental procedures are conducted in accordance with SOPs and methods and ensures SOPs and Method’s meet Company and FDA standards. 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. Oversees the review of compliance guidelines, industry trends, customer’s projects, validation efforts, and development efforts to ensure Microbiology/Environmental departments meet or exceeds 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 to 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 manner. 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 requirements. Works as a member of a team to achieve all outcomes Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements Performs all work in support of our

Values:

Collaboration, Courage, Perseverance, and Passion All other relevant duties as assigned 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 Environmental Monitoring Guidelines for Viable and Non-Viable Monitoring Ability to apply advances mathematical concepts such as exponents, logarithms, quadratic equations, linear regression, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, and correlation techniques. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to read, analyze, and interpret common scientific and technical journals, specifications, standard operating procedures, and standard testing procedures. Ability to write presentations and articles that conform to prescribed style and form. Ability to effectively present information to middle management. Proven strong organizational, time management, and project management skills. Demonstrated experience in coordinating project activities Strong organizational, interpersonal and communication skills – excellent command of the English language, both written and verbal Ability to be a self-starter, work independently and manage multiple priorities in a fast-paced and changing environment Ability to challenge the status quo in an effort to drive systemic change and improvements Working knowledge of GMP Proficiency with Word, Excel, MS Access, SAP (preferred) and statistical software Experience A minimum of 5 to 7 years of experience in Pharmaceutical Microbiology Laboratory under cGMP guidelines Education Bachelors Degree in Microbiology and 5 to 7 years of experience in Pharmaceutical Microbiology Laboratory under cGMP guidelines .Experience should include exposure and understanding in the following areas:

FDA, EP, ISO, AMMI

regulations, current LISP and Supplement in Microbiological and Environment requirements, Isolation and Identification of Microbial Isolates Knowledge, Skills and Abilities Exposure and understanding of the following areas:

FDA, EP, ISO, AMMI

Regulations