Job Description

POSITION SUMMARY :

The QC Sample Coordinator Associate I performs incoming and outgoing sample management for in process, release, and stability studies.

The Associate I complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements.

The Associate I also ensures samples are delivered in line with organizational standards, protocol specific requirements and client expectations.

POSITION RESPONSIBILITIES :

• Operate to the highest ethical and moral standards.
• Adhere to quality standards set by regulations and policies, procedures, and mission.
• 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 :

• Bachelor’s degree in Scientific discipline or associate’s degree and 0-1 years of industry experience or equivalent.
• 0 years of directly related laboratory experience OR equivalent.
• Ability to utilize email, word processing and spreadsheet software.
• Ability to compute basic arithmetic operations : addition, subtraction, multiplication, and division.

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

Additional Information

Position is Full Time, Monday-Friday, 8 : 00am-5 : 00pm . Candidates currently living within a commutable distance of Sanford , NC are encouraged to apply.

Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.

• 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
• Eligibility for potential yearly Bonus & Merit-Based Pay Increases

Eurofins is a M / F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Last updated : 2024-04-28