QC Microbiologist

QC Microbiologist Title: QC MicrobiologistLocation: Brooksville, FLType: Direct HireSchedule: M-FSalary: Competitive and Based on ExperienceThe QC department is responsible for microbiological and analytical cGMP testing of sterile and non-sterile products, raw materials, components and utilities. This includes routine microbiological and analytical testing of products for release and stability, development and validation of microbiological and analytical methods, monitoring and maintaining the laboratory in good quality, assisting in the validation and periodic certification of the manufacturing facility/utilities/equipment, developing and executing equipment protocols, and performing work in a safe, accurate and professional manner.The QC Microbiologist works with the microbiology Director and/or Supervisor to review processes and procedures, assist in testing as needed, and perform projects in the Microbiology department, as well as works closely with manufacturing and Quality Assurance for harmonization between departments.The employee should successfully meet schedules in a high quality and professional manner and ensure work areas conform to cGMP regulations, Standard Operating Procedures and Company Policies. Specifically, while working independently, this person will perform the following duties adhering to written Standard Operating Procedures (SOPs), USP/NF, or written work instructions:

Responsible for coordinating, executing, and implementing the results of projects that improve procedures, process, systems, and technique.Review of microbiology systems to identify areas where improvement or revision may improve accuracy, efficiency, and compliance.Responsible for microbiology quality control testing of raw materials, in-process, finished product and stability samples. Perform investigations, deviations, and troubleshooting in a technical role. Performing microbiology development and validation activities, such as but not limited to bacteriostasis and fungistasis, neutralization efficacy, LAL validation, and microbial enumeration validation.Perform microbiology support activities of the sterile manufacturing areas, such as environmental monitoring.Develop test protocols, review and write technical reports, write SOP s, and review stability data. Work closely with QA and QC Chemistry to implement procedures in compliance with regulatory requirements. Perform review of laboratory notebooks for accuracy and compliance to the analytical method.Write and perform review of QC microbiology reports.Set annual goals with supervisor to improve job and individual skills and abilities; Maintain a high level of quality of product and improved established efficiency and yield standardsAll other duties as assigned by management
Education:

Bachelor s Degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or equivalent with 5 years of experience in sterile pharmaceutical and/or biotechnology manufacturing.
Or

Equivalent combination of relevant education, experience and training
Experience:

Knowledge of microbiological laboratory techniquesKnowledge of aseptic techniqueExperience working in QC laboratoryAbility to learn new laboratory equipment and techniquesExcellent verbal and written communication skillsKnowledge of cGMPs, USP/EU regulations, and ICH guidelinesAnalytical reasoning, root cause analysis and problem solvingTechnical writing: write, read, understand, and interpret technical writing and instructionsMS Office skills; particularly Word and ExcelMath and calculation skillsMultitask and coordinate with operations and quality assurance simultaneouslyWork with a wide range of people to solve problems and resolve issuesWork in a fast-paced environmentAbility to maintain flexible task schedule and workflowHighly detail oriented with good record keeping skillsPositive personality with integrity and a commitment to American Injectable, Inc s missionExcellent people skills, with experience collaborating in a multi-disciplinary, diverse, and dynamic team

EOE/ADA