Openings >> Quality Assurance Manager
Quality Assurance Manager
Title:Quality Assurance Manager
Labor Type:Contract
Posting #:TF-004034-HA
Location:Allentown, PA

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Immediate need for a Quality Assurance Manager

Duration:    12+ Months

Location:    Allentown, PA


Key Responsibilities:

  • Applies Good Manufacturing Practices (cGMP) in all areas of responsibility.
  • Demonstrates and promotes the company vision.
  • Establishes procedures for maintaining quality standards.
  • Provides leadership in promoting and enforcing company quality requirements.
  • Evaluates and develops techniques designed to maintain awareness of SOP’s, CGMPS’s and clinical requirements.
  • Develops and manages Quality Assurance systems that will enhance and maintain products that meet quality specifications and standards.
  • Leads and successfully completes QA training sessions for CGMP’s, SOP’s, company requirements, etc.
  • Understanding of Regulatory requirements with respect to distribution of pharmaceutical product.
  • Experience in Good Distribution Practice (GDP) in relation to temperature controlled cold distribution, frozen distribution, and shipment.
  • Direct QA Supply Chain personnel in appropriate inspection procedures and techniques.
  • Completes the regular performance evaluation of QA Inspectors.
  • Assures that issues potentially affecting product quality/compliance are escalated to the attention of Senior Management.
  • Assures that issues are resolved in a timely manner and corrective actions are implemented accordingly.
  • Conducts all activities in a safe and efficient manner.
  • Other duties may be assigned to meet business needs.


Minimum Requirements:

  • Bachelor’s degree
  • A minimum of 4 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.
  • The individual must be able to perform each essential duty satisfactorily.
  • Experience mentoring junior staff and good conflict management skills.
  • Must have strong project management, statistical analysis, and communication skills
  • Must have good working knowledge of cGMP Regulations
  • Organizational skills are required in order to quickly retrieve needed documents
  • 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.
  • Proficient communication skills (both verbal and written)
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