Quality Assurance Inspector
$47,840–$66,560 year
On-siteAllentown, Pennsylvania, United States
Job Summary
Conduct daily inspections of pharmaceutical products, components, and labels within a cGMP environment, including approval of specifications, incoming inspections, and packaging electronic production orders. Perform material and process samplings while adhering to strict Good Manufacturing Practices and safety standards in cold room and freezer conditions. Resolve nonconforming issues by participating in root cause investigations and ensuring timely corrective actions. Document activities according to SOPs and communicate effectively with cross-functional teams to maintain site quality systems. Work weekends and overtime as needed, lifting materials up to 25 lbs occasionally.
Required Qualifications
- High School Diploma, or equivalent
- At least 2 years of experience in Pharmaceutical, or related regulated industry
- A minimum of 1 year of experience in Pharmaceutical or in a related, regulated industry
- High School diploma
- Familiar with Quality Systems (Change Control, Deviations, Complaint Management, Documentation Management, among others)
- Ability to work independently
- Must be willing to work various shifts and overtime depending on business needs
- Ability to read, understand, and follow the SOP's, Work Instructions and policies of a GMP environment
- Must meet applicable visual acuity/color blindness standards to perform visual inspections in a cGMP environment
- Must be able to lift 25lbs of materials occasionally
- Must be able to lift 10lbs of materials regularly
- Must be able to work in a refrigerated environment (2° C to 8° C) and freezer environment (-20° C) with provided protective wear
- Must be able to work in cold temperatures for more than one hour at a time
- Must be able to work in -20F temperatures for at least 15 minutes at a time
- Must be able to work in an environment requiring special personal protection equipment
- Must be able to stand and walk extensively on packaging floor
- Must be able to bend
- Must be able to perform activities requiring standing, bending and lifting
- Must be able to work Monday through Friday, 8 hours per day
- Must be able to work Saturday or Sunday
- Must be able to work 12 1/2 hour shifts
- Must adhere to all Good Manufacturing Practices (GMP) Safety Standards
- Must adhere to Cleanroom standards (no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair)
- Must not wear contact lenses
- Must wear safety glasses, gowning, gloves, lab coat, ear plugs etc.
- Must apply Good Manufacturing Practices (cGMP) in all areas of responsibility
- Must demonstrate and promote the company vision
- Must perform approval of specifications and Incoming Inspections on material (i.e. drug, components) and distribution shipments
- Must perform material and process inspections and samplings
- Must review and approve Packaging Electronic Production Orders
- Must participate in continuous improvement initiatives and assist with root cause investigations for nonconforming issues
- Must author, revise and follow all relevant SOP's/Work Instructions and accurately document activities as needed
- Must resolve and assure that issues potentially affecting product quality/compliance are raised to the attention of the Team Leader and/or Management
- Must assure that issues are resolved in a timely manner and corrective actions are implemented accordingly
- Must perform all activities in a safe and efficient manner
- Must have strong communication skills both verbally and written
- Must have the ability to problem solve and effectively ensure the site follows established quality systems
Desired Qualifications
- Associates degree
- Experience with cGMP regulations
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