Quality Assurance Manager Supply Chain

Location
Allentown, PA
Salary
Competitive
Posted
September 28 2017
Ref
55746BR
Position Type
Full Time
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

 

 

Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain.  With unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivaled expertise. We are exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labeling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards. http://www.fisherclinicalservices.com/



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.

  • Direct QA Supply Chain personnel in appropriate inspection procedures and techniques.

  • Works with Area Manager QA to periodically review significant aspects of operations related to quality in the incoming inspection, warehouse, and distribution environment.

  • Provides positive and critical feedback to employees relative to job performance.

  • Completes the regular performance evaluation of QA Team Leaders including the identification of development needs.

  • 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 is required.

  • 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.





  • Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands - Thermo Scientific, Applied Bio systems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. Apply today at http://jobs.thermofisher.com

     

    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.

     

     



    *IND-CCG

    #LI-KP1