Overview
Senior Specialist, QA OTF Jobs in Harmans, MD at Catalent
Job Title: Validations Manager
Location: Jackson, MO
Salary Range: $100,000 – $120,000 per annum
About Aivirtrix:
Aivirtrix is an industry leader in sterility assurance and medical device validation, committed to maintaining the highest levels of safety, quality, and regulatory compliance in the healthcare sector. We are seeking a Validations Manager to lead our validation technical support team and manage sterility assurance processes for our partners in the medical device industry.
Key Responsibilities:
· Lead and mentor the Validation Technical Support Team, ensuring compliance with internal procedures and industry regulations.
· Review and approve sterility assurance validation protocols such as:
Process Performance Qualification (PQ)
Microbiological Performance Qualification (MPQ)
Routine cycle requalifications
· Oversee validation activities for medical device partners, including cycle development, equipment configuration, and client collaboration.
· Assign, track, and manage validation activities to ensure efficiency and timely completion.
· Conduct annual validation performance reviews and analyze quality trends.
Qualifications & Experience:
· Bachelor’s degree in a STEM-related field preferred.
· 3+ years of experience in validation, quality assurance, or engineering, particularly in a regulated environment.
· In-depth knowledge of:
ISO 11135 (Ethylene Oxide Sterilization of Healthcare Products)
ISO 13485 (Medical Devices Quality Management Systems)
21 CFR Part 820 (FDA Quality System Regulation)
· Strong analytical and problem-solving abilities.
· Experience with ethylene oxide sterilization is highly preferred; other sterilization methods may be considered.
· Ability to effectively communicate with external clients regarding validation protocols and execution strategies.
Job Type: Full-time
Pay: $100,000.00 – $120,000.00 per year
Schedule:
8 hour shift
Education:
Bachelor’s (Required)
Experience:
Quality assurance: 4 years (Required)
ethylene oxide sterilization: 2 years (Preferred)
Location:
Jackson, MO 63755 (Required)
Ability to Commute:
Jackson, MO 63755 (Required)
Ability to Relocate:
Jackson, MO 63755: Relocate before starting work (Required)
Work Location: In person
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Title: Senior Specialist, QA OTF
Company: Catalent
Location: Harmans, MD
