Specialist, Quality Control USA - North Carolina - Durham (Treyburn)

Job Description

Position Description:

Specialist, Quality Control USA - North Carolina - Durham (Treyburn)

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 main function of the Specialist, Quality Control is to assist in the assurance of the quality of product through the performance of microbiological, chemical and analytical sampling and assays as well as interacting with Production, Quality Assurance, Validation and Facilities, and external resources, as necessary to support Manufacturing.

Additional Responsibilities

General

• Conducts release testing in support of product, including sterility testing, detection of residual moisture, average cell dry weight testing

• Conducts microbiological testing; evaluation of environmental microbiological samples

• Conducts environmental sampling to include active air and surface sampling and water sampling

• Evaluates data, conducts trouble shooting, process improvements, report writing, involvement in interdepartmental committees and projects

Business & Functional Expertise

• Completes assignments in alignment with department objectives

• Conducting In-Process and Release testing

• Conducting Environmental Monitoring of processes and on a routine basis

• Authoring Investigational, Corrective Action and Preventive Action, and Batch Quality Notifications

• Authoring Standard Operating Procedures

Problem Solving

• Identifies and resolves technical and operational problems in collaboration with colleagues and under guidance from department head

Impact:

Influence

• Communicates information, asks questions and checks for understanding

Accountability

• Accountable for own performance

Decision Making

• Makes decisions – guided by policies and procedures – on the shop floor

• Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes

Shift

1st Shift Days - Weekends Required

Sunday-Thursday

Position Qualifications:

Education Minimum Requirement:

• Bachelor of Science degree in Biology, Chemistry, Biochemistry, or related field

Required Experience and Skills

• Minimum 2 years in a laboratory environment

• Understanding and application of GLP and cGMPs

• Aseptic technique

• Performance of environmental and water systems monitoring

• Working in a team environment

Preferred Experience and Skills

• Strong verbal and written communication skills

Working Relationships

• Reports to Quality Control department head

• Interacts with employees within own department and other departments

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-f