Performs inspections of all phases of clinical packaging and manufacturing processes in order to assure the quality of operations and to verify compliance with government regulations, customer requirements and internal procedures.
Essential Duties and Responsibilities:
Applies Good Manufacturing Principles in all areas of responsibility.
Demonstrates and promotes the company vision.
Interprets batch paperwork, including packaging and manufacturing instructions, and stages product and components prior to startup.
Monitors or audits assigned clinical packaging and manufacturing operations on a regular schedule and performs and documents in-process inspections.
Operates testing equipment such as vacuum leak tester, torque tester, micrometers, Oxygen Analyzers and Environmental Monitoring Equipment.
Reviews batch paperwork and performs reconciliation of components and products.
Approves processing areas for production prior to startup.
Interacts regularly with production supervisors, line personnel, management/office staff and customers.
Pulls customer and FCS samples. Stores in-house samples after recording data into logbook.
Performs investigations and writes deviations as required.
Conducts all activities in a safe and efficient manner.
Other duties may be assigned to meet business needs.
Basic Minimum Qualifications (BMQ):
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required. Prior experience in a regulated industry preferred.
Education/ Experience (BMQ):
Two-year college degree or equivalent pharmaceutical/QA experience or equivalent combination of education and experience.
While QA Coordinator has no direct supervisory responsibility he or she must resolve issues and act in an advisory capacity requiring above average problem solving and communication skills with the ability to deal with employees at all levels.
Internal and External Contacts:
Internal – Operations technicians, Operations Management, Project management, engineering, QA management.
External – Customer representatives.
Ability and/or Skills (BMQ):
Good reasoning and problem-solving skills, basic math skills, good communication skills, basic computer skills. Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products. Comprehension of FCS SOP’s for effective execution.
40-45 hours per week, additional hours as required.
Light lifting, extensive standing and walking.
This position description is written as a guideline to inform Thermo Fisher Scientific Employees of what is generally expected of them at each job level. The description is not intended to be all encompassing or limiting in any manner; rather, it is hoped it will add understanding and better reflect the work performed at all levels of employment within Thermo Fisher Scientific. Duties and responsibilities other than those listed may be included as needed within the work group or the company as a whole.
The above information is for exclusive use within Thermo Fisher Scientific and may not be used or duplicated by others without written consent.
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