QC Microbiology Compliance Specialist - Military veterans preferred

The Quality Control (QC) Compliance Specialist (Microbiology) will support the QC Microbiology department with the development, implementation, and monitoring of Quality Control activities to ensure compliance to applicable procedures, policies, and regulations. Additionally, the QC Compliance Specialist will investigate laboratory quality events (Out of Specification, Deviations, CAPAs, etc.), improve the QC Training program, maintain the QC instrumentation program, and ensure audit readiness. Role Responsibility

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including: Investigate quality events by performing a thorough root cause analysis, plan science-based hypothesis testing, develop an effective Corrective and Preventive Action (CAPA) plan, and prepare a comprehensive report. Assist and coordinate with QC to implement and execute CAPAs. This may include creating and revising Standard Operating Procedures (SOPs), coordinating studies or validations, coordinating the purchase of new equipment, and performing effectiveness checks. Assist in maintaining the QC instruments within cGMP by scheduling preventive maintenance, calibrations, and re-qualifications with QC and/or third-party vendors. Assist with the qualification of purchased equipment. Assist in the development of the installation, operation, and performance qualification documents. Work with Quality Assurance (QA) to support and ensure inspection readiness. Represent and coordinate activities for QC during audits. Identify negative trends in QC performance, such as increased number of quality events (Out of Specification and Deviations). Identify gaps in practices, policies, and procedures. Develop, maintain, and report statistical analysis and metrics of QC data. Inform QC Supervisor and Senior Management of adverse trends. Support the development and execution of validation studies and research projects. Work with QA Training Specialist to provide necessary technical support for the training program pertaining to the QC department. Ensure compliance with all Federal, State, local and company regulations, policies, and procedures related to cGMP, Environment, Health and Safety practices. Provides leadership, guidance, and training to junior colleagues on a regular basis. May operate, maintain, and troubleshoot advanced analytical equipment. Test record and document review. May perform QC testing and other general laboratory duties as assigned. The Ideal Candidate

Here at Med-Pharmex we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly keen to hear from those who have/are: Bachelor’s degree in a scientific discipline is preferred and 3 – 4 years of direct applicable experience in the pharmaceutical/biotech industry or master’s degree with at least 2 years of experience in the pharmaceutical/biotech industry. Experience with Good Manufacturing Practices (cGMP’s) and Good Laboratory Practices (GLP). Experience with non-sterile and sterile environments within ISO 5, 7, and 8 classified locations. Proficient in Microsoft Office’s Excel, PowerPoint and Word. Knowledgeable in Microbiological Assay, Microbial Limit Testing, Purified Water Testing, Sterility Testing, and Environmental Monitoring. The Ideal Candidate For over 35 years, we’ve committed to serving the animal health community by providing products to extend the health span of companion animals and ensure a safe and abundant food supply. We believe every animal deserves proper care, that’s why we aim to create accessible and results-driven, quality products. Med-Pharmex, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Med-Pharmex Incorporated 2022. All Rights Reserved

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