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Manufacturing - (QA)

2 months ago

Raleigh NC United States Guerbet Full time
At Guerbet, we build lasting relationships so that we enable people to live better.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in the field of contrast products for the last 95 years, we continuously innovate.

Achieve, Cooperate, Care, and Innovate are the values that we share and practice.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube.

WHAT WE'RE LOOKING FOR:

Our Manufacturing- QA supports (or IPQE I) and is responsible for monitoring formulation, filling, sterilization, and packaging operations for compliance to site SOPs and cGMP including timely review of cGMP documentation at designated, critical, process points. Monitors the production/packaging areas for compliance. Inspects product samples to ensure compliance to Guerbet requirements. Participates in containment, recovery, issue escalation process, and corrective actions involving atypical quality events. Supports team members to ensure all sampling is accomplished in a timely manner and any defect related issues are addressed. This position is a night shift, 9pm - 5am Monday through Friday, and located at the Raleigh, NC site.

YOUR ROLE:

Monitor compliance to meet or exceed site SOPs/cGMPs during production and packaging operations.
Perform required QA inspections. (i.e., Sample defect detection)
Perform the QA review and approval of executed Production batch records real-time (RTR).
Perform QA review for completed Sterilization records and associated documentation.
Ability to participate in internal audits, as requested.
Provide support to the operations/packaging area, up to and including tasks such as packaging line clearance verification, material segregation/containment, low product fill response, rework reconciliations/accountabilities, and documentation real-time review.
Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, having functions of initial exception impact assessment, product containment, bracketing, initial scope identification, and direction of immediate actions to take prior to resuming processing.
Assist personnel in the generation of Formulation, Filling and Packaging area related exceptions, as needed.
Support investigations for minor classified exceptions, as needed.
Team member of Facilities meetings regarding operations Preventive Maintenance/Calibration/Work Order status and scheduling, as designated.
Participate as a team member during area shutdown or maintenance projects, as needed.
Perform weekly walkthroughs of the operations/packaging area and communicate any observations to associated area management.

YOUR BACKGROUND:

Education required/ preferred:

Associates degree in Science/Business preferred or equivalent industry experience. Bachelor’s degree in life sciences is a plus.

Experience:

Minimum 2 years of experience in a pharmaceutical QA/MFG environment is desired.

Preferred Skills/Qualifications:

ASQ inspection certification preferred; previous experience with statistical sampling plans (preferred); previous experience in investigation root cause analysis and/or writing (preferred).

Skills/Competencies:

Ability to work in fast paced environment
Ability to adjust work schedule to meet operations and customer demand
Must be able to wear appropriate personal protective equipment to insure safe execution of job responsibilities.

Other Skills:

Skilled competency with computers, MS Office software required.
Experience with pharmaceutical CAPA and Documentation systems (e.g., Trackwise, Metric Stream, etc.) is preferred.

The position routinely interfaces with various personnel from Formulation, Filling, Sterilization, Packaging, Laboratories, Facilities, Warehouse and QA.