Quality Assurance Specialist

2 weeks ago


Allentown, Pennsylvania, United States TekWissen ® Full time

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

Pay Rate: $26-$26 per hour

Company Overview:

TekWissen Group is a prominent workforce management provider, recognized for its expertise in biotechnology product development services. Our client is a leader in supplying 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 is committed to enhancing global health and safety through innovative solutions.

Role Summary:

  • The Quality Control Inspector will oversee the quality assurance of clinical products during primary and secondary packaging, as well as throughout warehouse and distribution operations.
  • This position demands meticulous attention to detail, strong defect identification skills, and effective communication abilities to collaborate with various teams in resolving issues.

Key Responsibilities:

  • Implement Good Manufacturing Practices (cGMP) across all responsibilities.
  • Exemplify and advocate for the company's vision.
  • Conduct approvals of specifications and inspections on incoming materials 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.
  • Ensure that issues impacting product quality and compliance are promptly escalated to management.
  • Guarantee timely resolution of issues and implementation of corrective actions.
  • Execute all tasks safely and efficiently.
  • Additional duties may be assigned to fulfill business requirements.

Minimum Qualifications:

  • Associate's degree or High School Diploma with a minimum of 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 and documentation management.
  • Ability to work in a refrigerated environment (35F to 46F) and a freezer (-20F) with appropriate protective gear.
  • Strong reasoning, problem-solving, basic math, and communication skills.
  • Willingness to work various shifts and overtime as needed.
  • Capability to work independently and master SOPs and policies in a GMP setting.

Physical Requirements:

  • No allergies to penicillin or cephalosporin products.
  • Ability to stand and walk extensively on the packaging floor.
  • Work schedule: Monday through Friday, 8 hours per day, with potential for overtime and weekend shifts.
  • Physical tasks include standing, bending, and lifting up to 25 lbs occasionally and 10 lbs regularly.
  • Exposure to cold temperatures for extended periods.
  • Must meet visual acuity/color blindness standards for performing inspections.

TekWissen Group is an equal-opportunity employer supporting workforce diversity.



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