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 located in Sanford NC.
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 :
Position is full-time Monday-Friday 8am-5pm 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 Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time