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Quality Inspector in Breinigsville,Pa
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QA Inspector (Pharma, Packaging, Inspections, GMP, FDA, Batch Records, SAP)

Apex Systems ALLENTOWN Contractor
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Quality Assurance (QA) Inspectors and QA packaging Leads needed for our client who is a global leader in the commercial packaging market, providing cutting-edge contract services, including serialisation, to the biotechnology and pharmaceutical industries in the Allentown, PA area.

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!

FDA/GMP Experience Required!

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 

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)

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 844-463-6178-6178

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

 

Skills required

Ensure Compliance
Measure Equipment
Product Quality Assurance
Quality Assurance
Statistical Process Controls
Implement Corrective Action
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Job ID: 968739

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WHAT WE DO:

Apex Systems is a division of the 2nd largest IT staffing and services firm in North America. From consulting to staff augmentation, we connect top tech talent with great companies in all industries.

OUR CREDENTIALS: 

Apex earned Inavero’s Best of Staffing™ Client Diamond and Talent Awards for providing superior service to clients and job seekers, putting the company in the top 2 percent of all U.S. staffing agencies.

SUPPORTING OUR CONTRACT EMPLOYEES:

We take the time to understand a candidate’s talents and needs to ensure a good match with companies for contract, contract-to-hire, and direct hire positions. Each recruiter within Apex is focused on a specific skill area within infrastructure, applications, and project management. This focused discipline enables our local recruiters to work directly with our candidate’s and focus their talent on the right position at the right time.

WHO OUR CUSTOMERS ARE: 

We serve Fortune 500, mid-market, and emerging companies from a wide variety of industries, including communications, energy, financial services, government services, healthcare, technology, and utilities. 

WHERE WE ARE: 

Apex has branches in over 70 locations across the U.S. and Canada and more than 1,000 employees dedicated to supporting the needs of our clients and contract team members. Visit www.apexsystems.com to find a local branch or connect with an Account Manager or Recruiter.

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