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QA Inspector (Pharma, Packaging, Inspections, GMP, FDA, Batch Records, SAP) in Allentown, PA at Apex Life Sciences

Date Posted: 11/21/2018

Job Snapshot

Job Description


QA Inspector (Pharma, Packaging, Inspections, GMP, FDA, Batch Records, SAP)

Quality Assurance (QA) Inspectors and QA packaging Leads needed! QA Inspectors with 1-5 yrs. of experience in Pharmaceuticals/ Biotech regulated environments in supporting Packaging/ Quality Assurance (QA). Ideal candidates will have an understanding of packaging inspection guidelines, QA, inspections, Metrology, and hands-on knowledge of Inspection Equipment (tape measure, calipers, scales etc.) for mechanical inspections using metric dimensioning.

Also required, strong Computer skills using Microsoft Office tools, ERP systems-SAP experience a plus i.e. experience making quality transactions within and ERP systems.

QA Lead or QA Supervisory experience a plus!

Qualifications

  • AS or BS degree with 1-3 years of Pharma. Medical Device, or Biotechnology exp. or related experience.
  • High School (HS) diploma with 4+ years industry experience in inspection, FDA, or GMP environment
  • Demonstrated ability to support Pharma QA, packaging, in compliance with GMP and FDA guidelines managing documentation batch records and utilizing SAP (Pharma, Packaging, Inspections, GMP, FDA, Batch Records, SAP)
  • MUST HAVE 1+ years prior GMP manufacturing experience in an FDA regulated environment
  • Ability to work independently as well as part of a team

Quality Assurance (QA)? SUPERVISORY EXPERIENCE desired!

Responsibilities

  • Packaging inspection, Quality Assurance (QA) Inspection, Calibrations, Metrology, and data management
  • Using packaging Inspection Equipment (tape measure, calipers, scales etc.) for mechanical inspections in metric dimensioning.
  • Apply strong computer skills to data management; using Microsoft Office tools, ERP systems-SAP; making quality transactions within and ERP systems
  • Applies Good Manufacturing Practices (GMP) in all areas of responsibility
  • Applies Good Documentation Practices (GDP) in all areas of responsibility
  • Performs approval of specification and incoming inspections on material (i.e. drug packaging, components)
  • Oversees operational processes for compliance
  • Performs hourly inspection of in Process Manufacturing/ Packaging
  • Release product to Batch Record Review team
  • Make corrections as instructed by Batch Record Review 
  • Performs and writes Deviations/ Complaints
  • Corrects or escalates Compliance concerns
  • Flexible to overtime (OT)

FOR IMMEDIATE CONSIDERATION email your resume to Samantha at sbarrett@apexlifesciences.com with 'Pharm QA Inspector' in the subject line.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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