Quality Assurance Inspector

2 weeks ago

Allentown, Pennsylvania, United States TekWissen LLC Full time
Job DescriptionOverview: TekWissen Group is a leading provider of workforce management solutions across the USA and internationally. This opportunity is with a client that specializes in the development of biotechnology products. The organization is committed to providing essential laboratory equipment, chemicals, supplies, and services that support healthcare, scientific research, safety, and education. With an impressive annual revenue of approximately $40 billion, our client aims to empower customers to create a healthier, cleaner, and safer world. Their global team is dedicated to delivering an exceptional combination of innovative technologies, convenient procurement options, and pharmaceutical services under their renowned brands.
Position: Quality Control Inspector
Location: Allentown, PA
Duration: 12 Months
Job Type: Contract
Work Type: Onsite
Shift Timings: Monday-Friday - 03:15 PM to 11:15 PM
Summary:
  • The Quality Assurance Inspector is responsible for ensuring the quality of clinical products throughout the packaging, warehousing, and distribution processes.
  • This role demands a meticulous eye for detail, the ability to identify defects and discrepancies, effective verbal and written communication skills, and collaboration with cross-functional teams to resolve issues.
Responsibilities:
  • Implement Good Manufacturing Practices (cGMP) in all assigned tasks.
  • Exemplify and advocate for the company’s vision.
  • Conduct approval of specifications and incoming inspections on materials (e.g., drugs, components) and distribution shipments.
  • Perform inspections and sampling of materials and processes.
  • Engage in continuous improvement initiatives and assist in root cause analysis for nonconformities.
  • Draft, revise, and adhere to all relevant Standard Operating Procedures (SOPs) and Work Instructions, documenting activities as necessary.
  • Identify and escalate issues that may impact product quality or compliance to the Team Leader and/or Management.
  • Ensure timely resolution of issues and implementation of corrective actions.
  • Conduct all activities safely and efficiently.
  • Additional duties may be assigned to fulfill business requirements.
Minimum Qualifications:
  • Associate's degree or High School Diploma with 2 years of relevant experience.
  • At least 1 year of experience in the pharmaceutical industry or a related regulated field.
  • Familiarity with Quality Systems (Change Control, deviations, complaint management, documentation management, etc.).
  • Ability to work in a refrigerated environment (35F to 46F) with provided protective gear.
  • Capability to work in a freezer (-20F) environment with provided protective gear.
  • Ability to work in potent compound suites with provided personal protective equipment (PPE).
  • Strong reasoning and problem-solving skills, basic math skills, effective communication skills, and basic computer proficiency.
  • Willingness to work various shifts and overtime as needed.
  • Ability to work independently.
  • Proficiency in understanding and adhering to SOPs and policies in a GMP environment.
Physical Requirements:
  • No allergies to penicillin or cephalosporin products.
  • Extensive standing and walking on the packaging floor to monitor activities.
  • Work schedule includes Monday through Friday, 8 hours per day, with potential for overtime and weekend work.
  • This position requires standing, bending, and lifting, with the ability to lift up to 25 lbs occasionally and 10 lbs regularly.
  • Exposure to cold temperatures for extended periods.
  • Exposure to -20F temperatures for brief intervals.
  • Potential exposure to atmospheric conditions requiring special personal protective equipment.
  • Must meet applicable visual acuity/color blindness standards for visual inspections in a cGMP environment.
TekWissen Group is an equal-opportunity employer supporting workforce diversity.

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