Sr. Manager, Sterility Assurance And Laboratory Operations
Elkton , MD 21921
Posted 1 week ago
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The Senior Manager, Sterility Assurance & Laboratory Operations is responsible for managing sterility assurance and laboratory operations. S/he will develop and maintain compliant programs in the areas of sterility assurance, environmental monitoring, biocompatibility, chemical and microbiology laboratory operations for Elkton, Maryland and Caguas, Puerto Rico facilities. S/he will manage sterilization processing operations in Elkton, MD. This individual will represent Terumo as a member of industry organizations in area of expertise.
- Provides leadership and technical direction for sterility assurance, microbiological methods, environmental monitoring and biocompatibility Actively support new product development and life cycle management for Elkton, MD and Caguas, PR facilities in area of expertise Manages gamma sterilization processing operations in the Elkton, MD facility ensuring compliance with all applicable quality and safety regulations including maintaining compliance as a contract sterilizer Manages solution preparation operations including preparation and testing of solutions for manufacturing in Elkton, MD Manages laboratory operations (microbiology and chemistry) supporting manufacturing and new product development Develops and directs the company's sterility assurance program including but not limited to, dose settings, dose audits, ethylene oxide sterilization cycle development and qualifications/re-qualifications, sterilization adoptions, environmental control, bioburden process control and microbial characterization Develops and directs company's biocompatibility program including material safety evaluations and manufacturing materials approval Develops and directs the company's environmental monitoring program including water, air, and product. Includes responsibility for verification of environmental conditions and facility certifications related to manufacturing environmental requirements Sets technical direction for sterilization strategies for internal and external contract sterilization. Establishes and maintains policies, procedures, work instructions and training associated in ones' functional areas ensuring compliance with all applicable regulations and standards. Continually examine the scope of testing services being performed to ensuring alignment with business needs and regulatory requirements Serves as technical expert in functional area for regulatory and external audits. Qualifies and supports auditing of contract laboratories and external sterilization vendors Manages relationships with stakeholders in different functions. Drives functional excellence through continuous improvement. Develops specific short-term and long-term plans and programs, together with supporting budgets. Prepare, communicate, and evaluate team goals and objectives. Ensures linkage of team goals to the Strategic Quality Plan. Perform other duties as assigned.
Knowledge, Skills and Abilities (KSAs)
Working knowledge of national and international regulations applicable to medical devices including; Quality System Regulations 21 CFR 820, Canadian Medical Device Regulations, ISO 13485, etc.
Extensive knowledge of standards and guidance's related to terminal sterilization (ethylene oxide and gamma), cleanroom environmental controls, microbiological methods and biological safety
Knowledge of terminal sterilization operations including demonstrated experience with development and validation of ethylene oxide and radiation terminal sterilization methods
Knowledge of radiation safety regulations and ability to complete required radiation safety courses.
Ability to analyze and interpret regulatory guidelines and standards.
Excellent communication skills with the ability to convey technical information in a clear and concise manner.
Strong organizational and planning skills.
Requires a four-year degree in a chemistry, biology, technical engineering or related science.
Minimum of 15 years of experience in medical devices or similar regulated industry, including 10+ years of associate supervisory experience.