Senior Specialist, Quality

Job Description

The Senior Specialist, Quality Control will be responsible for activities that support cGMP and regulatory compliance during microbiological method transfer/qualification and routine product testing to include the following:

• Microbiology and sterility assay method transfer and qualification

• Microbiology and sterility routine testing

• 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

• Execute test method transfer/qualification

• Trouble-shoot method and equipment issues as needed

• Sample management

• Planning and test method execution to meet established delivery timelines

• Laboratory maintenance including managing stock of reagents, consumables, and laboratory cleaning

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

• Review of laboratory generated data and results

• Has knowledge of cell culture propagation and maintenance procedures, and/or microbiological laboratory procedures

• 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 the site laboratory compliance to ensure adherence to regulatory requirements

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

• Support our Manufacturing Division Divisional and Quality initiatives

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

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

Education Minimum Requirement:

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

Required Experience and Skills:

• B.S. Degree in a science field required, preferably biology, microbiology, biological sciences

• Must have good technical writing skills and high attention to detail

• 5 years laboratory testing experience or equivalent educational laboratory experience

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

• Excellent communication skills

• Aseptic technique

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

• 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.

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. VETJOBS #EBRG

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