Sterility Assurance Manager – North Carolina – Competitive Package
I am representing an established, global health care provider who is on the search for a Sterility Assurance Manager. You will be responsible for ensuring site policies are in place to meet requirements for contamination control of cleanrooms, manufacturing processes, and products.
This role will offer you:
A genuine opportunity to make a difference, being exposed to a variety of development projects which have the potential to save livesA lot of mobility and autonomy in the role, while working with a strong leadership teamTo act as the Sterility Assurance SME for a state of the art manufacturing facilityCompetitive salary, stock purchase program, Tuition reimbursement, PTO, 401k match, Medical/Dental/Vision coverage
You will be responsible for:
Developing and driving continuous improvement initiatives within the Sterility Assurance programActing as a sterility assurance SME during audits and inspectionsOverseeing and managing microbiology laboratory activities - environmental monitoring, microbiology testing, microbial identificationWriting and reviewing environmental cleaning protocols to support cleaning practices and authoring SOPs to support continuous improvement and CAPAsResponsible for the training program for cleanroom and contamination control practices
Desirable experience and qualifications:
Significant experience with microbiology within an aseptic or sterile manufacturing facilityBS degree in Science, concentration in Biology or Microbiology, preferablySignificant GMP experience and strong understanding of current regulations for sterility assuranceStrong leadership/supervisory experience within a similar environmentExperience with regulatory inspections and audits
