QC Sample Coordinator (Wednesday-Sunday 2nd Shift)

Job Description

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

This role is on-site in Sanford, NC

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, Wednesday-Sunday, 3pm-11:30pm with overtime as needed. Flexibility to train M-F 8am-5pm may be needed. 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.

• 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.