Quality Control Sample Management Specialist

2 weeks ago


Sanford North Carolina, United States Eurofins USA PSS Insourcing Solutions Full time
POSITION SUMMARY:
The Quality Control Sample Management Specialist is responsible for overseeing the management of incoming and outgoing samples related to in-process, release, and stability studies.

This role requires adherence to established policies and procedures to ensure compliance with legal regulations, health and safety standards, and industry requirements.

The Specialist guarantees that samples are processed according to organizational standards, specific protocol requirements, and client expectations.

POSITION RESPONSIBILITIES:
Uphold the highest ethical and moral standards in all activities.

Comply with quality standards as dictated by regulations, policies, procedures, and the company’s mission.

Coordinate and execute workflows that support laboratory operations across multiple cGMP facilities.

Ensure timely and precise cGMP-compliant processing of incoming and outgoing samples and reference materials.

Accession samples into the Laboratory Information Management System (LIMS) and initiate the sample chain-of-custody.


Effectively manage all responsibilities to ensure the on-time availability of samples and reference standards in accordance with Sample Management Standard Operating Procedures (SOPs) and related protocols.

Assist in the implementation of initiatives aimed at process improvement.

Maintain data integrity and traceability throughout all processes.

Generate and preserve records in a manner that complies with regulatory standards.

Contribute to the oversight of the Sample Management laboratory.

Demonstrate the ability to independently follow established protocols and perform associated tasks accurately as per applicable SOPs.

Assist in the distribution of samples intended for various Quality Control laboratories.

Conduct sample aliquoting within a Biosafety cabinet utilizing aseptic techniques as required.

Support inventory management of all retained, reference, and reserve samples, including stability samples.

Facilitate timely and effective investigations of area deviations or corrective actions.

Collaborate with other functional areas and/or vendors to address issues, enhance processes, and improve service delivery.

Navigate protocol-related questions, issues, escalations, and changes with relevant project team members.

Coordinate information and communications for designated projects at the site level, including the identification and escalation of discrepancies as necessary.

Function effectively in both team-oriented and individual settings.

Exhibit excellent written and verbal communication skills.

Initiate and manage daily tasks efficiently.

Utilize strong organizational skills and meticulous attention to detail.

Maintain laboratory organization according to 5S principles and perform additional duties as required.

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