Sample Coordinator

• Coordinate and perform workflow for laboratory operations support of multiple cGMP laboratories.
• Timely and accurate cGMP compliant processing of incoming and outgoing samples and reference materials.
• Accession samples into LIMS Sample Management and initiates sample chain-of-custody.
• Successfully complete all responsibilities for on-time availability of samples and reference standard material in accordance with Sample Management SOPs and other associated SOPs.
• Assist with the implementation of process improvement initiatives.
• Ensure data integrity and traceability.
• Generate and maintains records in a regulatory compliant manner.
• Contribute to oversight of Sample Management laboratory.
• Ability to independently follow standard protocols performs associated tasks without errors per applicable SOPs.
• Assist in distribution of all samples destined for various QC laboratories.
• Perform sample aliquoting in a Biosafety cabinet using aseptic techniques as needed.
• Support inventory control of all retain reference and reserve samples including stability samples.
• Support for timely and effective investigation of area deviations or corrective actions.
• Interact with other functional areas and/or vendors to resolve problems enhance processes and service delivery.
• Work through Protocol questions issues escalations and changes with relevant project team members.
• Coordinate information and communications for designated projects at the site level including identification and escalation of discrepancies as needed.
•  Operate effectively in both a team and individual setting.
• Provide excellent written and oral communication skills.
• Initiate and manage day-to-day tasks effectively.
• Utilize excellent organizational skills and attention to detail.
• Maintain laboratory 5S organization perform additional duties as needed

Qualifications :

BASIC MINIMUM QUALIFICATIONS:

• Bachelors degree in Scientific discipline or associates degree and 0-1 years of industry experience or equivalent.
• Ability to utilize email word processing and spreadsheet software.
• Ability to compute basic arithmetic operations: addition subtraction multiplication and division.
• Authorization for employment in the United States.

PREFERRED QUALIFICATIONS:

• Moderate understanding of ICH Guidelines as they pertain to Stability Studies and programs.
• Knowledge of GMPs safety regulations and data integrity preferred.
• Proven fundamental use of LIMS systems
• Knowledge of material receipt and inventory control.

Additional Information :

This position is Full-Time Mon-Fri 8am-5pm with overtime as needed. Candidates currently living within a commutable distance of Holly Springs NC are encouraged to apply.

• Excellent full time benefits including comprehensive medical coverage dental and vision options

• Life and disability insurance

• 401(k) with company match

• Paid vacation and holidays

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time