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Careers at ThermoFisher Scientific

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Job ID :
43858BR
Location :
US - Pennsylvania - Allentown
:
Job Description

Responsibilities:

  • Applies Good Manufacturing Principles (cGMP) in all areas of responsibility.
  • Demonstrates and promotes the company vision.
  • Conducts all activities in a safe and efficient manner.
  • Schedules QA staff in the inspection and auditing of packaging/manufacturing operations
  • Works with QA and Production to complete batch paperwork accurately and expeditiously.
  • Periodically reviews all aspects of packaging operations as related to quality, staging, reconciliation, in-process inspection, label control, etc.
  • Provides leadership in promoting and enforcing company quality requirements.
  • Develops and directs Quality Assurance systems that will enhance and maintain products that meet quality specifications and standards.
  • Evaluates and develops techniques designed to maintain awareness of SOP’s, CGMPS’s and clinical requirements.
  • Assures that issues potentially affecting product quality/compliance are escalated to the attention of Management and/or Senior Management.

  • Assures that issues are resolved in a timely manner and corrective actions are implemented accordingly.
  • Leads and successfully completes QA training sessions for CGMP’s, SOP’s, quality, etc.
  • Provides positive and critical feedback to employees related to job performance.
  • Completes the performance evaluation of QA Inspectors including the identification of development needs.
  • Assures that inventory system status changes are completed accurately and completely.
  • Other duties may be assigned to meet business needs

Minimum Qualifications:

  • Associate’s degree

A minimum of 2 years of experience in Pharmaceutical or of a related, regulated industry and at least 2 years supervisory experience required.

  • Experience with Quality Systems (Change Control, deviations, complaint management, documentation management, among others), people management.
  • This position is responsible for the direct supervision of QA Inspectors on the shift.
  • Assures that issues potentially affecting product quality/compliance are escalated to the attention of Management and/or Senior Management.
  • Requires excellent supervisory skills and leadership ability. Must be comfortable with decision-making on quality issues. Requires ability to multi-task and prioritize.
  • Organizational skills are required in order to quickly retrieve needed documents
  • Must have extensive familiarity with packaging paperwork and a sound understanding of cGMP’s and SOP’s.
  • Extensive standing and walking on packaging floor in order to monitor room activities.
  • Work schedule, Monday through Friday, 8 hours per day. Additional overtime and weekend (Saturday or Sunday) work may be required.
  • The employee must occasionally lift and or move up to 20 pounds

Preferred Qualifications:

  • Bachelor’s degree
  • Experience interfacing with Regulatory bodies- FDA/EU/Health Canada/MPA
  • Must be comfortable with decision-making on diversified issues and communicating directly with customers on a routine basis.
  • Must have extensive familiarity with packaging paperwork and a sound understanding of CGMP’s and SOP’s.
  • Thorough knowledge of Current Good Manufacturing Practices and SOP’s.



Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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