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Quality Control Specialist

2 months ago

Allentown, Pennsylvania, United States TekWissen LLC Full time
Job DescriptionOverview
TekWissen Group is a prominent workforce management provider operating across the USA and internationally. The following opportunity is with one of our esteemed clients, a leader in biotechnology product development services. This organization is committed to providing essential laboratory equipment, chemicals, supplies, and services vital for 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 global team is dedicated to delivering an exceptional combination of innovative technologies, convenient procurement solutions, and pharmaceutical services under their renowned brands.
Position: Quality Assurance Inspector
Job Type: Contract
Work Type: Onsite
Shift: Monday-Friday AM to 02:45 PM
Job Responsibilities
  • Responsible for ensuring the quality of clinical products during primary and secondary packaging, as well as warehouse and distribution operations.
  • Requires meticulous attention to detail, strong defect detection skills, and effective verbal and written communication abilities to collaborate with cross-functional teams in problem-solving.
Education Requirements
  • Associates degree or High School Diploma with a minimum of 2 years of relevant experience.
Key Responsibilities
  • Implement Good Manufacturing Practices (cGMP) in all areas of responsibility.
  • Exhibit and promote the company’s vision.
  • Conduct approval of specifications and perform incoming inspections on materials and distribution shipments.
  • Execute material and process inspections and sampling activities.
  • Engage in continuous improvement initiatives and assist in root cause analysis for nonconforming issues.
  • Author, revise, and comply with 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.
  • Perform all activities safely and efficiently.
  • Additional duties may be assigned as needed to meet business requirements.
Knowledge, Skills, and Abilities
  • A minimum of 1 year of experience in the pharmaceutical or a related regulated industry, 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 equipment.
  • 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 required by business needs.
  • Ability to work independently.
  • Proficiency in reading, 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.
  • Regular work schedule of 8 hours per day, with potential for overtime and weekend work.
  • Physical demands include 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.
  • May require special personal protective equipment due to atmospheric conditions.
  • Must meet visual acuity/color blindness standards for performing visual inspections in a cGMP environment.
TekWissen Group is an equal opportunity employer supporting workforce diversity.