Vacancy expired!
When you're part of the team at Thermo Fisher, you'll do important work, like helpingcustomers in finding cures for cancer, protecting the environment or making sure our food issafe. Your work will have real-world impact, and you'll be supported in achieving your careergoals.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.
Review production orders to ensure all information contained within is accurate per applicable reference documents and also complies with all customer requirements.
Perform EBR QA certification of production orders to ensure all information contained within is accurate per applicable reference documents and also complies with all customer requirements.
Review and approval of part number item specifications to ensure all information contained within is accurate per applicable reference documents and also complies with all customer requirements.
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 preferred and/or equivalent years of experience, with minimum of 2-3 years in Pharmaceutical or of a related, regulated industry.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.
Vision requirements for this position: Near Vision Acuity with minimum 20/40 corrected vision (clear vision at 20 inches or less), color vision, and the ability to adjust focus.
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 Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
Vacancy expired!