Senior Analyst 1, Quality Control Sample Control (Friday to Monday)

Fujifilm•Holly Springs, NC

17h•Onsite

About The Position

The Sr. Analyst 1, QC Sample Control works independently with limited supervision and guidance from their manager to ensure all samples managed by the Sample Control team are handled and documented in accordance with applicable internal procedures. This role is responsible for handling samples manufactured at FDB Holly Springs, samples and reference materials from external sources, coordinating stability samples and protocols within the sample control team. This role is also responsible for coordinating with key internal stakeholders on the transport of QC samples from Holly Springs to external testing laboratories and support continuous improvement projects and SOP revisions by providing input into the sample handling process. A very high attention to detail and the ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success. This role is included in routine on-call and weekend support, as needed.

Requirements

Excellent attention to detail.
Seeks opportunities for improvement and suggests ideas for improvement projects
Advanced technical writing and problem-solving skills
Excellent verbal and written communication skills.
Ability to review and interpret data
Ability to present information to the team
Ability to develop and assign tasks according to a structured plan.
Ability to overcome and respond to challenges
Ability to complete tasks independently and with occasional guidance from Supervision as needed
Ability to implement structured plans
Ability to support audits and client interactions
Must be flexible to support 24/7 manufacturing facility

Nice To Haves

1 year of experience with the use of Labware LIMS and/or working with a LIMS in a cGMP Quality Control department or in an FDA regulated industry (drugs/biologics)
Experience using Trackwise system
Experience working in a laboratory environment is desired
Basic familiarity with fundamental statistical tools to analyze data in relation to trends results
Ability to learn and incorporate lean lab and six sigma six principles into daily work environment.

Responsibilities

Executes setup of Sample Management lab including authoring procedures, sample collection in support of facility qualification, determining lab supplies for QC department, logbook creation for QC, and additional activities, as needed
Manages and performs daily sample collections to support utility PQ and cleaning validation studies.
Executes sample reconciliation to ensure all samples were collected as per approved LIMS plan or protocol
Maintains and supports equipment alarms during off hours and move samples, as required
Executes movement of QC samples from Manufacturing to the QC labs and maintains sample chain of custody and GMP documentation
Serves as advisor for program management by overseeing Stability Sample Sets, proper storage conditions and pulling samples per approved protocols and internal procedures to ensure proper management of all on-going studies in accordance with ICH guidelines and client requirements
Receives, inspects, and inventories reference materials and samples from external sources. Will handle temperature excursion alerts to client if necessary
Documents receipt, storage, and movement by making entries into Labware LIMS and/or internal sample chain of custody forms or logbooks
Collaborates cross-functionally to address issues that arise from manufacturing, laboratories, or the warehouse
Authors and reviews SOPs, protocols, reports, change management reports, CAPAs and Trackwise deviations related to Sample Management and Stability Studies
Creates CoA’s and result summary reports to support batch disposition
Participates in continuous improvement projects and SOP revisions by contributing input to the process, and supports associated procedural updates
Ensures sample integrity in all aspects of working with samples and reference materials
Assist in training new analysts, as needed
Performs other duties, as assigned