Supervisor, QA Microbiology

Employer
Ortho Clinical Diagnostics
Location
Raritan, New Jersey, US
Salary
Competitive
Posted
Jul 16, 2021
Closes
Jul 27, 2021
Ref
2319554695
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
The Career PotentialOrtho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work. The OpportunityAs the company continues to grow, we are seeking a Supervisor for QA Microbiology. The Supervisor will manage the staff and operation of the microbiology lab, including the execution and completion of all finished, bulk, and in-process product testing, reviewing and approving data under cGMP regulations. This role is considered a subject matter expert within the functional area providing technical support to various areas of the company.The ResponsibilitiesLead departmental personnel in completion of assignments and projects. Review production schedules, prioritize and assigns work to staff. Monitor processes and adjusts resources as necessary to handle workflow.Perform data reviews and prepares documentation of product release ensuring on time completion to meet production requirements. Enter test results into the current material management system. Monitor and evaluate product testing results and microbial profiles of environmental areas identifying and responding to adverse quality trends.Ensure laboratory is in a state of control and compliance. Including calibration and maintenance of laboratory equipment, maintaining supplies inventory levels and employee training.Subject matter expert on microbiological principles, theories, practices and methodology to align with current procedures and Pharmacopoeias. Maintains current knowledge of cGMPs and regulatory issues/guidelines. Partner and support Manufacturing, Validation, Compliance and Product Support with projects, audits and process improvements. Develop, write, and implement necessary protocols and final reports.Investigate nonconformances, microbial data excursions (MDE) and OOS/OOT. Create nonconformances and CAPAs as required. Lead problem solving and root cause analyses activities to eliminate recurrence of nonconformances. Facilitate timely completion of investigations and provide guidance on immediate corrective actions.The IndividualBS Degree in Microbiology or Biology4-6 years of microbiology laboratory experience in a regulated manufacturing environment or equivalent combination of education and experience. Supervisory experience preferred.Knowledgeable of microbiological testing, principles, theories, practices and methodology to align with current procedures and Pharmacopoeias. Including concepts of microbiology, quality control testing methods, bioburden testing, endotoxin testing, organism identification, growth promotion, environmental monitoring and validation techniques.Must be able to understand and scientifically interpret data utilizing analytical skills and practical experience in medical device and microbiological applications.Strong technical writing skills to successfully resolve audit findings, product nonconformances, root cause investigations, customer complaints, Corrective/Preventive Actions, validation protocols and/or to improve product design.Experience in performing and writing investigations. Experience working in an FDA regulated environment. Knowledge of Good Manufacturing Practices, ISO 13485 and all applicable regulations and standards.Experience with MODA and VITEK preferredStrong organization skills as a leader in a laboratory environment required.Strong verbal and written communication skillsUp to 10% travel - DomesticKey Working RelationshipsInternal - Manufacturing/Operations, Compliance, Engineering, Validation, ProcurementExternal - Regulatory agencies, vendors/suppliersEOE/AA Disability/Veteran#ZR
Full time

Similar jobs

Similar jobs