2nd Shift Quality Assurance Inspector

Location: Buena, NJ

Job Summary:

Responsible for overseeing of Quality Assurance in Topical areas for packaging and compounding and the Sterile Manufacturing suite.

Essential Responsibilities:

  • Oversee the activities in the sterile manufacturing and packaging areas. Assisting in all activities as required and reviewing documentation when needed.
  • Review pre and post manufacturing and packaging records to ensure compliance with cGMPs and company standards.
  • Conduct daily balance functionality checks in packaging.
  • Conduct Line Clearance inspection and provide Line Clearance in conjunction with packaging personnel.
  • Conduct Hourly/semi hourly finished goods attribute checks, weight checks, torque checks, seal integrity. Record as per Fill and Assembly Specifications.
  • Perform AQL inspections on finished product as needed.
  • Pull finished goods samples as per Fill and Assembly Spec. Deliver to Labs. Record as per SOP.
  • Report nonconformance incidents to Packaging Supervision and Quality Assurance Management.
  • Establish scope of con conformance units and determine remediation plans with manufacturing personnel.
  • Conduct packaging terminal audit of finished goods.
  • Aid in Investigations for product non conformation.
  • Conduct re-inspection of packaging line after foreign find.
  • Assist in review of pre-approval for filling batch records.
  • Assist in the maintenance of related SOPs related to quality inspections.
  • Collect and prepare all final packaged customer samples.
  • Keep Manager informed of all key quality findings and issues.
  • Assumes other activities and responsibilities from time to time as directed.

Qualifications:

  • HS Diploma and minimum of 1-2 years of experience in QA for the pharmaceutical industry.
  • Minimally 1 year experience in working with Sterile Manufacturing or Injectables.
  • Solid demonstrated ability to work on multiple projects and meet timelines.
  • Strong knowledge of cGMP requirements.
  • Practical experience with document control and QA support of manufacturing.
  • Excellent organizational skills.
  • Demonstrated ability to work on multiple projects and meet timelines.
  • Detail oriented.
  • Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities.
  • Well-developed interpersonal skills.  Ability to get along with diverse personalities.
  • Good written and oral communication skills.

Physical Demands/Factors:

  • Physical Demands
    • Mobile/Ambulatory
    • Ability to lift
    • Sight
    • Available to work second shift as required.
  • Environmental
    • Inside and outside work
    • Move between buildings
    • Temperature variations
    • Sit and stand for long periods

 This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs

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