Company Description
The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
If you’re looking for a rewarding career, a place to call home, apply with us today!
Job Description
POSITION SUMMARY:
The QC Sample Coordinator Associate II performs incoming and outgoing sample management for in process, release and stability studies. This role is also responsible for reference standard inventory and reconciliation to support all laboratory testing. The Associate II complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements, as well as ensures samples are delivered in line with organizational standards, protocol specific requirements and client expectations.
ROLE 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.
- Provide 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.
- Ensure all team members are trained and able to successfully complete all responsibilities for on-time availability of samples and reference standard material in accordance with Sample Management SOPs and other associated SOPs.
- Recognize and assist with the implementation of process improvement initiatives.
- Ensure data integrity and traceability.
- Generate and maintain records in a regulatory compliant manner.
- Contribute to oversight of Sample Management laboratory, including storage units and other equipment, under supervision of senior management.
- Follow standard protocols, performs associated tasks without errors per applicable SOPs.
- Assist in distribution of all samples destined for various QC laboratories. This includes scheduling and performing timepoint pulls for stability.
- Support LIMS builds for stability studies.
- Support minor SOP writing and revisions.
- 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.
- Lead tours of sample management area if requested.
- Maintain laboratory 5S organization, perform additional duties as needed.
Qualifications
BASIC MINIMUM QUALIFICATIONS:
- Bachelor’s degree in Scientific discipline or associate’s degree and 2-4 years of industry experience or equivalent.
- 1+ 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.
PREFERRED QUALIFICATIONS:
- Understanding of ICH Guidelines as they pertain to Stability Studies and programs.
- Proven ability to perform sample collection/distribution/testing/shipment.
- Proven ability in performing stability timepoint pulls.
- Knowledge of GMPs, safety regulations and data integrity.
- Proficient 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.
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