Stability Program/Sample Receipt Coordinator

4 weeks ago


Durham, United States bioMérieux SA Full time

Description Position Summary:

The Stability Program/Sample Receipt Coordinator is responsible for the management of incoming samples for QC department testing and the scheduling of stability study sample testing.

Primary Responsibilities:

Manages the cGMP system for incoming QC samples.

Receives and logs samples as per SOP; Accountable for maintaining sample inventory and chain of custody.

Manages cGMP system for stability study samples. Prepares protocols, requests and schedules testing in collaboration with the QC department biochemistry and microbiology laboratories.

Acts as the primary contact for monitoring system after business hours for stability samples. Investigates and resolves any excursions or other deviations.

Coordinates with the manufacturing department to identify and receive finished product samples to be put on stability.

Authors stability sample testing protocols and obtain necessary approvals prior to study initiation.

Identifies out of trend or atypical stability sample testing results and support initiated/on-going investigations.

Provides stability study data as necessary to support internal and external audit requests.

Adds required stability testing results into LIMS per approved stability protocols, as appropriate.

Works collaboratively with other departments and functional peer groups.

Identifies areas of deficiency and implements practices to improve sample receipt an scheduling processes.

Recommends and authors revisions to QC department standard operating procedures (SOPs) related to sample receipt, scheduling and storage and assists in implementation.

Participates in required training activities.

Performs additional job related duties as assigned by management.

Education, Skills, & Experience:

BS/BA in a scientific field with a minimum of 2 years relevant experience required. Industrial QMP experience preferred.

In lieu of a Bachelor’s Degree, an Associate’s Degree with a minimum of 4 years of progressively responsible experience working in a regulated, GMP environment.

Experience in the use of software tools for data entry and analysis such as (LIMS); Well-developed technical writing skills.

Experience supporting regulatory audits (i.e FDA, MDSAP, ISO, MDDAP)

Demonstrated experience with laboratory sample receipt, documentation, scheduling and storage.

Experience in authoring stability study testing protocols.

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