Job Description

** POSITION SUMMARY:**

The QC Sample Coordinator performs incoming and outgoing sample management for in process, release, and stability studies. A QC Sample Coordinator complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements. They will ensure samples are delivered in line with organizational standards, protocol specific requirements and client expectations.

** POSITION RESPONSIBILITIES:**

• 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.
• 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

Position is full-time, Monday-Friday 3:00 pm - 11:30 pm with overtime as needed. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply.

What we offer:

• 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 M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.