Quality Assurance Manager Supply Chain/TMO-REQ-004034/Allentown, Pa

  • Location
    Allentown, Pennsylvania
  • Job type
    Contract/Temp to Hire
  • Salary
    $ 27 - $ 34 / Hour
  • Category
    Industrial & Manufacturing - Supply / Material

Job Description 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 Qualifications: 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) Preferred Qualifications: 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.

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Reference number US_EN_99_028082_11838438