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ICONMA, LLC Specialist Quality Control in United States

Our Client, a Biopharmaceutical company, is looking for a Specialist Quality Control for their Holly Springs, NC location. Responsibilities:

  • Candidates should be experienced in managing GMP Samples, Aliquoting Samples, Picking up Samples in Manufacturing, Shipping/Receiving GMP samples, and Stability Sample management

  • Under general supervision, this position will perform tasks associated with establishing routine procedures and defining business process in support of the QC Sample management group.

  • This position will be responsible for one or more of the following activities, but not limited to:

  • Assist with procurement activities for consumables and critical reagents for lab start up.

  • Support the startup and qualification/validation of the Sample Management and Stability Laboratories in a GMP environment.

  • Assist with establishing the processes and procedures for sample handling and storage.

  • Develop/Perform routine Sample Management laboratory procedures:

  • Sample Manufacturing Sweeps

  • Aliquot cGMP samples

  • Manage Sample Shipments

  • Contract Testing Laboratory (CTL) Management

  • Maintaining and operating specialized equipment as applicable

  • Initiating and / or implementing changes in controlled documents.

  • Support routine activities over the weekends and public holidays as required.

  • Ideal candidate must be familiar with documenting tasks within LIMS.

  • Must learn and comply with safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory log books (as applicable).

  • Develop/Perform Sample Management laboratory procedures:

  • Sample Manufacturing Sweeps

  • Aliquot cGMP samples

  • Manage Sample Shipments

  • Contract Testing Laboratory (CTL) Management

  • Maintaining and operating specialized equipment as applicable

  • Initiating and / or implementing changes in controlled documents.

  • Support routine activities over the weekends and public holidays as required.

    Requirements:

  • Sample Management lab experience is required.

  • Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

  • Sample Management lab experience

  • Familiar with documenting tasks within LIMS

  • Experience establishing the processes and procedures for sample handling and storage.

    Why Should You Apply?

  • Health Benefits

  • Referral Program

  • Excellent growth and advancement opportunities

    As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.

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