QA Incoming Inspector — Regulated Packaging & Audits

Sharp Clinical Services; Allentown (Lehigh County); On-site; USD 42,000 - 52,000; Full time

Job summary

Sharp Clinical Services is seeking a QA Incoming Inspector Level I to perform visual and physical inspections of packaging and bulk products. You will ensure compliance with item specifications, document results, and operate multiple testing instruments.

The role requires attention to detail, accuracy, and the ability to follow procedures. Training peers and assisting with controlled substances handling are also part of the duties.

Qualifications

• High School diploma, or equivalent.
• Two years of quality or manufacturing experience in a regulated environment.
• Knowledge of cGMP (21CFR 210, 211, 820) and/or DEA regulations for controlled substances.
• Attention to detail.
• Strong communication skills (verbal and written), interpersonal skills, team building and organizational skills.
• Ability to read, write and speak the English language and follow verbal and written instructions.
• Skill and ability to perform work in a thorough and accurate manner.
• Ability to use a wide variety of test and measurement equipment.
• Ability to follow and comply with procedures.
• Ability to develop and produce reports and documentation.
• Ability to work overtime (weekend – Saturday and/or Sundays).

Responsibilities

• Inspect packaging components and bulk products.
• Participate in internal, external or regulatory audits as directed by senior management.
• Verify documentation (CoA, CoC, Bill of Lading) matches labeling and item specifications.
• Execute sampling and inspection of components and bulk product and document results.
• Operate testing equipment (FT-IR, Keyence, Magna-Mike, UV-Vis, Global Vision) and document results.
• Read calipers and rulers; use measuring tools as required.
• Maintain electronics system for inventory, training and documentation storage.
• Participate in internal, customer, and regulatory audits as requested.
• Train designated peers at management request.
• Assist with receiving, transfer and shipping of controlled substances.

Skills

Attention to detail

Verbal and written communication

Teamwork and collaboration

English language proficiency

Education

High School diploma or equivalent

Tools

FT-IR

Keyence

Magna-Mike

UV-Vis

Global Vision

Job description

Sharp Clinical Services is seeking a QA Incoming Inspector Level I to perform visual and physical inspections of packaging and bulk products. You will ensure compliance with item specifications, document results, and operate multiple testing instruments.

The role requires attention to detail, accuracy, and the ability to follow procedures. Training peers and assisting with controlled substances handling are also part of the duties.