Sterility Assurance Specialist
4 weeks ago
Job Summary: We are seeking a highly skilled Sterility Assurance Scientist I to join our team at PharmaForce (Ohio). The successful candidate will be responsible for ensuring the sterility and quality of our products.
Key Responsibilities:
- Write technical protocols and reports for studies, trend reports, and investigations.
- Perform investigations for out-of-specification (OOS) or out-of-trend (OOT) results.
- Plan daily workload to meet requirements and manage Corrective and Preventive Actions (CAPAs).
- Initiate Change Controls to procedures requiring modifications and complete gowning qualifications to enter the Aseptic Processing Areas (APA).
- Address any problems that arise and bring quality issues to Management attention.
Requirements:
- Bachelor's Degree in Microbiology, Biology, or a related field.
- Minimum one-year experience in the pharmaceutical industry, food industry, cosmetics, medical devices, Laboratory Pathology, or a similar FDA-regulated environment.
- Knowledge of Aseptic Technique/Clean Room Experience preferred.
- Technical writing skills required.
- Organized individual with strong attention to detail and excellent communication skills (oral and written).
- Proficient in Microsoft Office and Trackwise and MODA/LIMS or equivalent software.
Physical Environment and Requirements:
- Physically able to wear cleanroom/protective gowning and equipment.
- 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 assigned duties.
Equal Opportunity Employer: PharmaForce (Ohio) celebrates diversity and is 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, national origin, disability status, or protected veteran status.
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