Responsible for QC / Environmental operations, which includes implementing and maintaining appropriate environmental sampling and microbiology testing systems; supervising, training and evaluating personnel; analyzing and interpreting monitoring results; and making appropriate decisions and recommendations to address trends, issues or significant observations. Demonstrates leadership in a fast-paced manufacturing setting and operates with minimal oversight and a clear understanding of business and regulatory demands. Exhibits rigorous scientific and supervisory skills, a strong practical knowledge of biopharmaceutical manufacturing environmental monitoring and testing, and excellent understanding of current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) compliance requirements. Efficiently manages staff and other resources to address scientific, business and regulatory needs in an effective and timely manner. Remains current regarding best practices in environmental monitoring and testing and develops or modifies procedures to stay fully compliant with the evolving expectations of all stakeholders. Formulates strategies for routine monitoring and microbiology testing, prepares protocols and standard operating procedures (SOPs), and reviews and approves work of subordinates. Conducts, schedules and directs monitoring and testing activities, keeping appropriate records consistent with regulatory guidance, business needs and client expectations. Gathers and collates results of environmental testing, identifies trends, interprets implications, and recommends procedural changes to drive improvement. Communicates with Management, Quality Assurance and others as appropriate. Participates in development and implementation of validation plans and protocols. Effectively assists with client and regulatory interactions as appropriate.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
Software Powered by iCIMS
www.icims.com