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Quality Assurance Specialist
2 weeks ago
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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