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/
- 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.
- 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).
- 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.
At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story
to tell. Join us and contribute to our singular mission—enabling our customers to make the
world healthier, cleaner and safer. Apply today 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.
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