QC Specialist II Raw Materials and Consumables

Job Summary

This individual will provide Quality Control oversight and support for KBI NC biopharmaceutical manufacturing facilities including routine cGMP manufacturing operations related to the sampling, release, shipment, and management of raw materials and consumables. Provides QC support of the KBI NC Regional Warehouse that services all KBI sites in North Carolina. Supports Quality Control Raw Material (QCRM) team responsible for the sampling and oversite of testing of raw materials. Performs daily activities to assure timely inspection, sampling, and testing of materials to meet manufacturing needs, batch disposition dates, and project priorities. Coordinates with approved third-party laboratories related to release testing of raw materials. The QC Specialist I / II / Sr Specialist provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients. Acts as QCRM support for internal and external audits. In addition to the afore mentioned tasks, the Senior Specialist, is able to investigate OOS results as part of laboratory investigations (LIRs), investigate deviations, provide change control assessments for area of expertise, and act as change owner for change controls under their purview.

Job Responsibilities

Performs compliant sampling of raw materials used for cGMP manufacturing.

Assures activities comply with required procedures and cGMP requirements.

Tracks status of samples and receives test results from contract laboratories.

Responds to LIR events following internal procedures as needed.

Maintains raw material sampling areas and equipment to required cleanliness classification and cGMP state. This includes execution of routine cleaning, non-routine cleaning, and GMP audits.

Assists in the level loading of work across the QCRM team to ensure raw material release timelines are achieved in support of manufacturing batch release and project timelines.

Prepares and reviews cGMP documentation for release of materials used in manufacturing operations.

Supports relevant investigations, change controls, CAPAs, and QC-related projects.

Attends relevant operational meetings in support of manufacturing operations and material / consumable disposition activities.

Supports client audits and regulatory inspections as required. Other activities as assigned by management.

Minimum Requirements

For Specialist I, Bachelor’s degree and 3 years of experience, Associate’s degree and 4 years of experience, or high school diploma and 5 years of experience in a cGMP-regulated environment within the Biopharmaceutical industry;

For Specialist II, Bachelor’s degree and 5 years of experience, Associate’s degree and 6 years of experience, or high school diploma and 7 years of experience in a cGMP-regulated environment within the Biopharmaceutical industry;

Demonstrated interpersonal skills, ability to work in a team environment, high attention to detail, and strong problem resolution skills.

Experience in material inspection / release for use in cGMP / commercial manufacturing is required.

Knowledge of US and EU cGMP requirements is beneficial.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Math Ability

Basic math skills are required. Ability to apply concepts of basic algebra and statistics.

Physical Demands Sitting for long periods of time working at a computer workstation. Pushing and pulling up to 30 pounds.

Salary Range :   $51,584 - $70,928

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

About KBI :

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500 customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit .

Salary : $51,584 - $70,928