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Quality Control Coordinator - several positions in Phoenix, AZ at APEX Systems

Date Posted: 5/17/2019

Job Snapshot

Job Description

Job #:  971298
Rapidly growing pharmaceutical company in Phoenix is looking to hire several Quality Control Coordinates in our areas of Chemistry, Microbiology, and Manufacturing/Process Control. Duties will vary by department. We are expanding our workforce to keep up with production needs and are looking for quality, talented team members to join our team!  These positions will be working during the day on first shift and start as soon as qualified candidates are identified.  Join our team now and expand with our company as we grow!
 
Position Summary:
Ensure site-specific compliance with Standard Operating Procedures (SOPs). 
 
Essential Duties/Responsibilities:
  • Perform and review the Daily Compliance Verification Checklist, document results, and report to immediate supervisor.
  • Microbiology: Perform and/or coordinate completion of:
    • Environmental monitoring and documentation e.g. personnel monitoring, air bioburden, surface bioburden, temperatures, and particle counts 
    • Collect Environmental Monitoring samples as necessary
    • New staff training
    • Sterility tests via microbiological plating, aseptic technique qualifications, and media fill process validations.
  • Chemistry: Perform and/or coordinate completion of:
    • Chemical Analysis of raw materials and final products using the UPLC/HPLC, ICP/OES, titrations, pH, and other test methods
    • Solution preparation from 50 mls to 2 liters
    • New staff training
    • SOPS must be followed exactly and careful documentation is critical
    • Washing glassware and other lab support duties as needed
  • Manufacturing: Perform Document review of manufacturing batch records:
    • Verify that raw materials meet specification limits
    • Verify accuracy of labeling
    • Perform final disposition of Batch
    • Verify that product test results meet specification limits
    • Verify that all documentation is complete
    • Document non-compliance and evaluate if further investigation is needed 
  • Submit samples to the appropriate labs for chemical assay and microbial tests.
  • Track vendor equipment calibration and maintenance records and assess for deviations.
  • Enter test results or summaries into the pharmacy specific monthly and quarterly Quality Assurance report template.
  • Under the direction of supervisor, document results of deviation and complaint investigations, causal analysis, corrective actions and preventive actions
  • Support Internal & External audits.
  • Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).
  • Participate in staff meetings

 
Responsibilities:  Other Duties 
  • As assigned by immediate supervisor.

 
Qualifications - Experience/Training/Education/Certification/Etc:
 
Required:
  • B.S. or B.A. degree in Science (Biology, Microbiology, Chemistry, Pharmacy)
  • Minimum of 2 years’ experience in a QC/QC department of a pharmaceutical, medical device, or other GMP industry

 
Apply today for immediate consideration to phoenix@apexlifesciences.com
 
 
 
 
 
 
 
 
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.