Speakers' Bureau Directory: Justi
|Degree:||B.S. in Biology|
Saxonburg, Pennsylvania 16056
|Primary Employer:||Other; Other Contract Sterilization Service (for Medical Device & Pharmaceutical Industry)|
|Scientific Specialty:||Pharmaceutical/Medical Device; Other N/A|
|Job Title:||Quality Assurance Manager/Corporate Sterilization Specialist|
|Years in position:||17|
Video Call Type:N/A
|Day to day responsibilities:
Responsible for managing the quality systems that are essential for demonstrating the adequacy of an irradiation process to sterilize various types of medical devices, pharmaceuticals, biologics, and labware products that are critical to the global healthcare markets. Also provide microbiology & technical support to Synergy Health business development groups working with new and current customers. Conduct internal & supplier audits. Host customer & regulatory audits.
What do you love about your job?
The challenges that arise from customer needs that may be the result of either: new entrepreneurs/businesses without any knowledge of how to validate a sterilization process for their product, new product concepts requiring alternative methods of sterilization, and/or new regulatory requirements that can be a hindrance to advancing technologies that require terminal sterilization as an endpoint for their product.
Degrees, experience, license(s), and skills required for position:
Typically a minimum 4 year degree. Licensing and certification are resume boosters but rarely a requirement for positions related to sterilization engineering; however, if seeking to transition to a quality or regulatory role, certifications (ASQ & RAC) are strongly encouraged, particularly for large corporations which often have numerous marketed products of varying classifications and who receive far greater scrutiny from the various departments of the FDA. If seeking to stay and advance within a research/technical role, higher degrees (M.S., Ph.D.) are often encouraged and sought by high-end manufacturers. Required skills: math, logic, technical reading/writing, scientific method, verbal communication, common sense.
Tips/Advice for how to secure a job in microbiology upon graduation:
Start with an undergraduate (microbiology focused curriculum) degree having learned basic hands-on microbiology techniques. Pursue internship or position with companies that manage internal laboratory resources or with contract laboratory services. If interested in higher degree and greater earning potential, pursue additional schooling (and/or certification resources) with evening or online courses (where possible) that are compatible with managing a full-time job. Companies will often reimburse tuitions as part of their benefits package. Higher degrees without actual prior private sector experience can hurt chances for employment if not willing to begin career at an entry-level position. Additionally, employers may not consider graduate degrees based on the assumption that the candidate would be seeking a higher salary than someone with an undergraduate degree (for entry-level position).