Quality Assurance Specialist

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. We are currently seeking a Quality Control Inspector for our client, a prominent player in the biotechnology sector, focused on product development services. This organization is committed to delivering essential laboratory equipment, chemicals, 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 enhance global health, safety, and cleanliness. Their dedicated global team is focused on providing an exceptional combination of innovative technologies, convenient procurement solutions, 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 Control Inspector will oversee the quality assurance of clinical products throughout the packaging, warehousing, and distribution processes.
  • This role demands meticulous attention to detail, strong defect identification skills, effective verbal and written communication, and collaboration with various teams to resolve issues.
Responsibilities:
  • Implement Good Manufacturing Practices (cGMP) in all responsibilities.
  • Promote and embody the company's vision.
  • Conduct approvals of specifications and incoming inspections on materials and distribution shipments.
  • Carry out inspections and sampling of materials and processes.
  • Engage in continuous improvement initiatives and assist in root cause analysis for nonconformance.
  • Draft, revise, and adhere to all relevant Standard Operating Procedures (SOPs) and Work Instructions, documenting activities as necessary.
  • Identify and escalate issues affecting product quality or compliance to the Team Leader or Management.
  • Ensure timely resolution of issues and implementation of corrective actions.
  • Perform all tasks safely and efficiently.
  • Additional duties may be assigned as needed.
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, including Change Control, deviations, and complaint management.
  • Ability to work in a refrigerated environment (35F to 46F) with appropriate protective gear.
  • Capability to work in a freezer environment (-20F) with necessary protective equipment.
  • Experience in working within potent compound suites with provided PPE.
  • Strong reasoning and problem-solving abilities, basic math skills, and good communication capabilities.
  • Willingness to work various shifts and overtime as required.
  • Ability to work independently and effectively.
  • Proficiency in understanding and adhering to SOPs and policies in a GMP setting.
Physical Requirements:
  • No allergies to penicillin or cephalosporin products.
  • Extensive standing and walking on the packaging floor to monitor activities.
  • Standard work schedule of Monday through Friday, with potential for overtime and weekend work.
  • Physical demands include standing, bending, and lifting up to 25 lbs occasionally and 10 lbs regularly.
  • Exposure to cold temperatures for extended periods.
  • Exposure to -20F temperatures for brief intervals.
  • Compliance with 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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