4854 - Sterility Assurance Project Manager - Nashville, United States - DeRoyal

Description

Sterility Assurance Project Manager

New Tazewell, TN, USA

Req #2110
DeRoyal is an Equal Opportunity/Affirmative Action employer.

Interviewing and hiring practices at DeRoyal do not discriminate on the basis of race, color, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, genetic information, veteran status or any other category protected by law.

Sterility Assurance Project Manager
Biology Degree and Lab or Sterilization experience is a plus. Good administrative organization skills. Quality or Regulatory understanding a plus

ESSENTIAL DUTIES AND RESPONSIBILITIES
include the following. Other duties may be assigned
Maintain ETO personnel monitoring and medical surveillance in controlled personal files.
Review and update all new products submitted for bioburden and residual testing. Review test packages and generate work instruction files.
Update procedures and forms as indicated by standards / customer requests
Compile laboratory data for quarterly CAPA meetings.
Annually, assess all QMS records and adjust quality goals.
Issue, review and compile data for annual customer surveys.
Review all customer test data, excluding routine BI testing.
Generate special project invoicing information (customer studies/validations/re-qualifications)
Review / approve all training files for completeness and issue retrains where necessary.
Coordinate validations and re-qualifications between sterilization and lab.
Incoming inspection / approval of lab process materials.
Review and maintain emissions control testing for permit.
Evaluate / maintain approved process materials / suppliers.
Maintain supplier files (not purchasing files).

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