Quality Control 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. The following opportunity is with one of our esteemed clients in the biotechnology sector, renowned for its product development services. This organization is committed to delivering essential laboratory equipment, chemicals, and services that support healthcare, scientific research, safety, and education. As a global leader in the scientific field, our client generates approximately $40 billion in annual revenue and aims to empower customers to enhance health, safety, and environmental sustainability.
Position: Quality Assurance Inspector
Location: Allentown, PA
Duration: 12 Months
Job Type: Contract
Work Type: Onsite
Shift: Monday-Friday AM to 02:45 PM
Job Responsibilities
  • Responsible for ensuring the quality of clinical products throughout the packaging, warehousing, and distribution processes.
  • Requires meticulous attention to detail, strong defect identification 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 assigned areas.
  • Promote and exemplify the company's vision.
  • Conduct approval 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 nonconformance issues.
  • 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 or Management.
  • Ensure timely resolution of issues and implementation of corrective actions.
  • Execute all tasks in a safe and efficient manner.
  • Additional duties may be assigned as needed to meet business objectives.
Knowledge, Skills, and Abilities
  • At least 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 (35°F to 46°F) with provided protective gear.
  • Ability to work in a freezer environment (-20°F) with provided protective gear.
  • Experience working in potent compound suites with appropriate 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.
  • Proficient in reading, understanding, and following 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 consists of Monday through Friday, 8 hours per day, with potential for overtime and weekend work.
  • Physical tasks 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 -20°F temperatures for brief intervals.
  • May require special personal protective equipment due to atmospheric conditions.
  • Must meet 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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