QC Sample Coordinator

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.