Your Role:

\nThe Quality Control Specialist is an individual contributor who works within the QC Stability team. Dedicated to supporting cross-functional teams and driving continuous improvement within the stability program to maintain high standards of quality and regulatory readiness.\n

Key Responsibilities:

\nAssist in stability sample pulls at each timepoint\nOversee proper storage, handling, and inventory of stability samples in temperature-controlled chambers\nPrepare/aliquot R D stability samples\nAssist in Reference Standard Generation activities\nGenerate weekly stability status reports for management using Excel\nIndependently manage competing priorities with limited instruction\nCollaborate with management to establish and meet targets and timelines by providing weekly forecasts\nIdentify and recommend solutions to potential procedure, process and system gaps\nMaintain and track stability QC testing documentation (STWs and QC test method forms)\nReview documentation from the

QCA, QCM

departments and 3rd party vendors\nCompile data for Stability Summary of Testing reports (SofT's)\nPrepare Stability Summary of Testing reports, Certificates of Analysis, and Statements of Testing\nIdentify opportunities to optimize stability workflows and contribute to process improvement initiatives\nSupport internal and external audits\nPerform other duties as requested by management to support quality activities\nMaintain the quality compliance of all QC operational areas\nEnsure and apply GMP throughout operations

QC Stability Sample Lifecycle Maintenance:

\nPrepare

STW/LIMS/label generation\nAliquot
sterile aliquoting of samples into assay specific individually labeled tubes\nShip/Track
track samples weekly to maintain on-time target delivery\nDispose
coordinate sample inventory and disposition\n

Position Type/Expected Hours of Work:

This role is a full-time onsite position. Days and hours of work are Monday through Friday unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.\n

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $32.30

$40.

38 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

You have a \"bring it on!\" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.\nYour written and verbal skills are out of this world, and you communicate with clarity and confidence.\nYou have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.\nYou are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.\n

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. 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