QC Review Specialist I - 1st Shift

NOW Health Group INC•Bloomingdale, IL

19d•$27 - $33

About The Position

The QC Review Specialist I reviews laboratory documentation and procedures to ensure compliance. The role reviews analytical testing data from contract laboratories and the QC department, supports production and laboratory activities, and helps maintain compliance with cGMP, internal SOPs, and specifications. It also contributes to laboratory investigations, procedure updates and training, process improvement, and workplace safety.

Requirements

Bachelor's degree (B.S.) or equivalent from a four-year college or technical school in laboratory science, such as Chemistry or Biology, or a related field.
At least one year of experience in laboratory and/or QA/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 and work transparently and professionally with peers and management.
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, deadline 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.
Ability to apply fractions, percentages, averages, ratios, proportions, and the metric system to practical situations.
Ability to perform the stated physical demands, including frequently lifting or moving up to 25 pounds; reasonable accommodations may be made.

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 of data reports, including electronic storage of 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 in support of production, stability studies, method development, QA, R&D, and laboratory operations.
Use product safety review and material qualification in data review and disposition.
Provide information for laboratory non-conformance investigations and escalate identified 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 the change process 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 and participate in the safety program, including training, hazard reporting, safety suggestions, and communicating safety information to new employees.