Manager, Quality Operations Microbiology

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Manager, Quality Operations (QO) Microbiology will be responsible for leading and developing the QO Microbiology team, while managing day-to-day operation and activities of the associated laboratories.

Job responsibilities include but are not limited to:

• Schedule daily testing of laboratory samples based on internal metrics and production needs.

• Author/review technical documents, method transfer/qualification reports, standard operating procedures, change controls, and investigations for the performance of laboratory methods

• Initiates and contributes to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Preventative Actions

• Trouble-shoot method and equipment issues as needed

• Train and mentor laboratory analysts on test methods, techniques, and good documentation practices

• Review of laboratory generated data and results

• Provide active support during audits and inspections (regulatory, internal, safety)

• Assist regulatory groups by providing documentation to support the approval of licensure supplements and new product license registrations

• Collaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirements

• Influence, motivate, and energize individuals at all levels in the organization

• Support our Manufacturing Division and Quality initiatives

• Additional project and routine testing support as required by vaccine analytical testing requirements

• Other duties as requested by Quality leadership to support effective laboratory operations and performance metrics

Education Minimum Requirement:

• B.S. Degree in Microbiology or equivalent Science field

Required Experience and Skills:

• Minimum 3 years supervisory experience

• Minimum 10 years GMP based laboratory testing experience.

• Must be able to work independently and within a team environment

• Strong technical writing skills and high attention to detail.

• Excellent communication skills

• Demonstrated ability to lead by example and with integrity

Preferred Experience and Skills:

• Knowledge of cGMPs

• Root cause analysis methodology

• Experience in Compendia microbiological testing methods

• Experience in analytical method transfer

• Sterility testing (compendia/rapid microbiological methods)

• Growth Promotion

• Microbial identifications using MALDI-TOF technology

• Method Development

• Method Validation

• Equipment Validation

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. #EBRG #VETJOBS

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand