QC Inspector

Job Title: Quality Control Inspector

Full Time | Location: Camarillo, CA 93011

Reports To: Quality Control Supervisor

FLSA Status: Non-Exempt

2 Opening - 5:30 AM PST – 2 PM PST

2 Opening - 6 AM PST – 2.30 PM PST

Monday to Friday; 40 hours a week; occasional weekend (example they work on Saturday 4 AM PST Start time and finish work fast)

These roles will include performing QC duties in a class 7 cleanroom wearing appropriate PPE (bunny suit, gloves, booties, face mask, etc.) Familiar with BoM’s and engineering drawings.

Job Summary

• The Quality Control Inspector inspects materials, parts, and products at different stages of production to ensure compliance with company standards and performs various quality control inspections, checks, and tests of products during the manufacturing process.

Manager Notes:

• Interpreting Blueprints
• Using Measuring Tools (Calliper, Measuring tapes etc)
• Clean Room environment (97% of time candidate will be working here)
• No Streat attire: need to wear PPE or Scrubs or quality attire (SaniSure will provide)
• Inspection of Raw materials etc and final inspection (Visual)
• Overtime as per business need (10-hour shift) and some weekend work (overtime pay is there)
• Incentive Programs for weekend works
• Non-Conformance knowledge/Experience
• 1 Month internal training
• 2 rounds of interview

Essential Functions:

• Preform activities related to quality inspections and compliance with applicable regulatory authorities.

• Initiate nonconformance reports (NCR).

• Record observations and make recommendations for improving processes.

• Conduct inspection and testing related to:

? Incoming product.

? First article.

? In-process.

? Final.

• Support cross-functional department investigations related to non conformance findings.

• Ensure all inspections and procedures are properly completed and documented.

• Perform pre- and post-inspection of product as part of gamma irradiation process.

• Approve or reject raw materials with respect to quality standards and communicate results to all pertinent parties.

• Initiate nonconformance reports (NCR) for all non-conforming material identified throughout operations.

• Prepare and submit metrics reports to the QC Supervisor or Lead.

• Comply with all safety requirements ensuring work areas meet standards.

• Review and release job order documents.

• Wears appropriate PPE when working in ISO environment including, scrubs, coverall suit, mask, protective eyewear, gloves, shoe covers, and similar.

• Recommend and participate in continuous improvement initiatives

• Perform other duties as assigned

Education

• High School Diploma or equivalent.

• Minimum 3 years of experience in quality control inspections.

Required Experience & Competencies

• Understanding of global pharmaceutical product regulations with ISO 9001 and/or 13485:2003 and 21 CFR Parts 210 and 211 and/or Part 820.

• Demonstrated ability to perform GMP operations following detailed SOPs, good documentation practices.

• 1+ years’ experience with technical documentation in the areas of quality manufacturing that includes quality inspections and corrective actions in a pharmaceutical or medical device environment.

• Solid organizational and planning skills.

• Excellent written and communication skills. Consistently demonstrates strong interpersonal skills in interactions across departments and with external vendors and customers.

• Must be able to work effectively and efficiently in a team environment.

• Able to perform all tasks with an uncompromising dedication to quality, including integrity and trust, sound judgement, intellectual honesty, pragmatism, decisiveness and conviction.

• Good general mathematical skills.

• General knowledge and use of measuring devices such as calipers, tape measures, rulers, pin gauges

• Good computer skills.

• Possesses working knowledge of ERP system, preferably Syteline