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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
Summary:
- The Quality Control Inspector will oversee the quality assurance of clinical products throughout the packaging, warehousing, and distribution processes.
- This role demands meticulous attention to detail, strong defect identification skills, effective verbal and written communication, and collaboration with various teams to resolve issues.
- Implement Good Manufacturing Practices (cGMP) in all responsibilities.
- Promote and embody the company's vision.
- Conduct approvals of specifications and incoming inspections on materials and distribution shipments.
- Carry out inspections and sampling of materials and processes.
- Engage in continuous improvement initiatives and assist in root cause analysis for nonconformance.
- Draft, revise, and adhere to all relevant Standard Operating Procedures (SOPs) and Work Instructions, documenting activities as necessary.
- Identify and escalate issues affecting product quality or compliance to the Team Leader or Management.
- Ensure timely resolution of issues and implementation of corrective actions.
- Perform all tasks safely and efficiently.
- Additional duties may be assigned as needed.
- Associate's degree or High School Diploma with 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, deviations, and complaint management.
- Ability to work in a refrigerated environment (35F to 46F) with appropriate protective gear.
- Capability to work in a freezer environment (-20F) with necessary protective equipment.
- Experience in working within potent compound suites with provided PPE.
- Strong reasoning and problem-solving abilities, basic math skills, and good communication capabilities.
- Willingness to work various shifts and overtime as required.
- Ability to work independently and effectively.
- Proficiency in understanding and adhering to SOPs and policies in a GMP setting.
- No allergies to penicillin or cephalosporin products.
- Extensive standing and walking on the packaging floor to monitor activities.
- Standard work schedule of Monday through Friday, with potential for overtime and weekend work.
- Physical demands include standing, bending, and lifting up to 25 lbs occasionally and 10 lbs regularly.
- Exposure to cold temperatures for extended periods.
- Exposure to -20F temperatures for brief intervals.
- Compliance with visual acuity/color blindness standards for visual inspections in a cGMP environment.
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