QC Review Specialist I - 1st Shift

Now Foods•Bloomingdale, IL

About The Position

The QC Review Specialist I reviews laboratory documentation, procedures, and analytical results to ensure accuracy and compliance with cGMP, internal SOPs, and specifications. The role coordinates sample submissions to contract laboratories, tracks testing through receipt and electronic storage of reports, and reviews data to support production, stability studies, method development, and QA, R&D, and laboratory operations. The specialist supports investigations and timely resolution of invalid or problematic testing, participates in SOP review, revision, and training, and initiates changes to erroneous methods or specifications. The role also maintains metrics, contributes to process improvement, completes assigned projects, and follows safety and GMP requirements. It supports safe laboratory and production operations by following safety procedures, participating in safety training, reporting hazards, and helping communicate safety information to new employees. This is a first-shift, full-time position. The stated pay range is $26.70–$33.40 per hour.

Requirements

Bachelor's degree or equivalent from a four-year college or technical school in a laboratory science such as Chemistry, Biology, or a related field.
At least one year of experience in laboratory and/or QA or regulatory compliance.
Advanced computer skills, including Microsoft Word and Excel.
Knowledge of industry quality control procedures, standard operating procedures, and compliance.
Strong working knowledge and application of cGMP regulations.
Ability to read and interpret analytical data, product specifications, departmental instructions, and procedure manuals.
Ability to communicate transparently and professionally with peers and management.
Ability to apply fractions, percentages, averages, ratios, proportions, and the metric system to practical situations.
Ability to compare primary test results with specifications to determine whether results meet requirements.
Ability to gather, generate, and interpret data and instructions.
Ability to use Excel or other database software to track outside laboratory testing and metrics.
Ability to communicate professionally with outside sources by phone, email, or in person.
Strong time management, attention to detail, verbal and written communication, listening, decision-making, troubleshooting, problem-solving, and organizational skills.
Ability to self-start, handle multiple tasks, and prioritize tasks.

Nice To Haves

Experience with database management systems such as Oracle, LIMS, and Epicor.
At least one year of experience with general laboratory procedures, instrumentation, and analytical instrumentation.

Responsibilities

Ensure samples are sent to appropriate contract laboratories with applicable documentation.
Track contract laboratory testing from sample shipment through receipt and electronic storage of data reports.
Review analytical test results from contract laboratories for correctness and accuracy.
Review basic analytical test results generated by the QC department for compliance with cGMP, internal SOPs, and specifications.
Use product safety review and material qualification in data review and disposition.
Provide information for laboratory non-conformance investigations and escalate issues to management.
Communicate with management to support timely resolution of invalid or problematic testing.
Perform or facilitate SOP review, revision, and training; create or review procedural SOPs.
Initiate change processes for erroneous methods or specifications.
Maintain metrics for reviewed data, analyst training, errors, and investigations.
Initiate and participate in process improvement activities.
Complete special projects assigned by management.
Comply with safety and GMP requirements; follow safety rules, participate in safety activities, report hazards, and help communicate safety information to new employees.