Quality Assurance Evaluator

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 leading provider of workforce management solutions across the USA and globally. The opportunity presented is with one of our esteemed clients who specializes in the development of biotechnology products. This organization is committed to providing essential laboratory equipment, chemicals, supplies, and services that are vital in the fields of 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.

Job Summary:

  • The Quality Assurance Inspector will be accountable for ensuring the quality of clinical products processed through both primary and secondary packaging, as well as warehouse and distribution operations.
  • This role necessitates a meticulous attention to detail, an acute ability to identify defects and errors, and strong verbal and written communication skills to collaborate effectively with cross-functional teams in problem-solving efforts.

Key Responsibilities:

  • Implement Good Manufacturing Practices (cGMP) in all assigned responsibilities.
  • Exemplify and advocate for the company’s vision.
  • Conduct approvals of specifications and incoming inspections on materials (e.g., drugs, components) and distribution shipments.
  • Execute material and process inspections and sampling procedures.
  • Engage in continuous improvement initiatives and assist with root cause analysis for nonconformance issues.
  • Draft, revise, and adhere to all relevant Standard Operating Procedures (SOPs) and Work Instructions, ensuring proper documentation of activities as required.
  • 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.
  • Perform all tasks in a safe and efficient manner.
  • Additional duties may be assigned as necessary to meet 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, along with a high school diploma.
  • Familiarity with Quality Systems, including Change Control, deviations, complaint management, and documentation management.
  • Ability to work in a refrigerated environment (35F to 46F) with provided protective equipment.
  • Capability to work in a freezer (-20F) environment with provided protective wear.
  • Experience working in potent compound suites with necessary personal protective equipment (PPE).
  • Strong reasoning and problem-solving skills, basic mathematical abilities, effective communication skills, and fundamental computer skills.
  • Willingness to work various shifts and overtime as dictated by business needs.
  • Ability to work independently.
  • Proficiency in reading, understanding, and adhering to SOPs and policies within a GMP environment.

Physical Requirements:

  • No allergies to penicillin or cephalosporin products.
  • Ability to stand and walk extensively on the packaging floor to monitor activities.
  • Work schedule consists of Monday through Friday, 8 hours per day, with potential for additional overtime and weekend work.
  • Position requires standing, bending, and lifting, with the ability to exert and lift up to 25 lbs occasionally and 10 lbs regularly.
  • Exposure to cold temperatures for extended periods.
  • Exposure to -20F temperatures for brief durations.
  • Potential exposure to atmospheric conditions requiring special personal protective equipment.
  • Must meet applicable visual acuity and color blindness standards for performing visual inspections in a cGMP environment.

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

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