Quality Assurance Technician
Status: Full-Time / Hourly, Non-Exempt
Job Summary:
The Quality Assurance Technician is responsible for ensuring compliance with
printing/packaging industry Quality standards through meticulous inspection
of product at each stage of production, thorough and accurate documentation, and
coordinating QA processes at all levels to ensure compliance. This role is
documentation-heavy and requires hands-on involvement in quality operations. The
ideal candidate has pharmaceutical-specific QA experience and a strong
understanding of cGMP-compliant processes.
Responsibilities:
* Inspects first article, in-process, and final release of product to ensure
conformance with regulatory and customer specifications.
* Conduct periodic rounds to all presses, cutting machines, folders, and
pack-outs to ensure conformance of product.
* Verifies that cartons of finished products are properly packed and labeled.
* Maintain organized and accurate QA records and documentation of Deviations,
CAPAs, NCRs, and Customer Complaints for KPI reporting.
* Performs rub tests and bar code scans when applicable.
* Performs periodic comparator checks of printed products.
* Collaborate with QA Lead to gather information for
all investigations, internal and external audits.
* Support the rework or disposition of defective product when necessary,
ensuring all actions are thoroughly documented.
* Keep work area clean and organized.
* Adhere strictly to company Standard Operating Procedures (SOP’s) and current
Good Manufacturing Practices (cGMP’s).
* Other duties as assigned.
Qualifications:
* High School diploma or GED required; with a minimum of one year of experience
in quality control, preferably in the printing industry.
* Working knowledge of computer systems.
* Strong attention to detail, organization, and effective communication
skills.
* Must have at least a basic understanding of Deviations, CAPAs, SOPs, batch
records, and other regulatory documentation.
* Must be able to read a ruler to 1/64”.
* Must be able to sit, stand, stoop, reach, and walk for extended periods.
* Ability to lift up to 50 pounds and use hands and fingers dexterously in
continuous and repetitive motions.