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Nature and Scope
This position in the Sterility Assurance Department will be primarily responsible for writing investigations/Excursions for Environmental and Personnel Monitoring with regards to assurance of sterility and being involved in technical projects from protocols to final reports.
Essential Duties And Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
• Write technical protocols and reports for studies, trend reports, etc.
• Perform investigations for out-of-specification (OOS) or out-of-trend (OOT) when requested.
• Plan daily workload to meet requirements.
• Report any issues with Aseptic Technique or cGMP compliance to Sterility Assurance Management.
• Work independently with minimal supervision.
• Manage Corrective and Preventive Actions (CAPAs) and ensure closure in a timely manner.
• Initiate Change Controls to procedures requiring modifications.
• Completing gowning qualifications to enter the Aseptic Processing Areas (APA).
• Addresses any problems that arise and bring quality issues to Management attention.
• Perform any other tasks/duties as assigned by management.
Education Requirements And Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
• Bachelor’s Degree in Microbiology, Biology or related field required.
• Minimum one-year experience in the pharmaceutical industry, food industry, Cosmetics, medical devices, Laboratory Pathology or similar FDA regulated environment, required.
• Knowledge of Aseptic Technique / Clean Room Experience preferred.
• Technical writing skills required.
• Organized individual with strong attention to detail.
• Excellent communication skills (oral and written).
• Proficient in Microsoft Office.
• Proficient in Trackwise and MODA/LIMS or equivalent software or equivalent preferred.
• Good work ethic and highly motivated.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
Physical Environment And Requirements
• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
• Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.
• Job activities require long periods of sitting and/or standing per assign duties.
Employee must be able to occasionally lift and/or move up to 25 pounds.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.
