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QA Shop Floor Specialist

Pfizer


Location:
Ayer, MA 01432
Date:
03/29/2018
2018-03-292018-04-29
Pfizer
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Job Details

All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. As we continue to develop healthcare products and expand our business globally, we are consistently looking for new talents.







Right now, we are seeking highly qualified candidates to fill the position of Quality Assurance Shop Floor Specialist.







Contract: Regular



Location: Italy-Catania







The main responsibilities for the specific function are as follows:



Observing, receiving, and otherwise obtaining information from all relevant sources (verification of SOP application on the floor, timely and correct filling of SOI, Forms, Logbooks, Line Cleaning and clearance performance review, processes and flows verification, etc.)



Inspecting Equipment, Structures, or Material - Inspecting equipment, structures, or materials to identify the cause of errors or other problems or defects.



Monitor Processes, Materials, or Surroundings - Monitoring and reviewing information from



materials, events, or the environment, to detect or assess problems.



Being a reference point for manufacturing personnel and Supervisors on the shop floor.



Documenting/Recording Information - Entering, transcribing, recording, storing, or



maintaining information in written or electronic/magnetic form.



Making Decisions and Solving Problems - Analyzing information and evaluating results to choose the best solution and solve problems.



Updating and Using Relevant Knowledge - Keeping up-to-date technically and applying new knowledge to your job.



Performing Special Audit (Walkthroughs)



Analyzing Data or Information - Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.



Work with Site Training Team to Identify the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.







Education, Skills and Experience:



Chemical Engineering is a plus for the Pen position



At least 5 years of experience in an aseptic facility. Preference with experience in the QO organization;



Proven Knowledge in problem solving techniques



Thorough knowledge of global GMP requirements and expectations



Have a well balanced and strong GMP knowledge and good understanding of key



processes/systems/equipment/utilities



Ability to interact with regulatory agency inspections



Thinking Creatively - Developing, designing, or creating new applications, ideas, relationships







Global Job Level: J040



**Main Responsibilities**



Observe, receive and act upon appropriately information relative to Manufacturing and Testing Operations via consistent Shop Floor presences, including but not limited to review of documentation, such as in-progress batch records or work orders, logbook and form entries, labeling of product and processes as required by SOP;



Inspect Equipment, Structures, or Material - Inspecting equipment, structures, or materials to identify the cause of errors or other problems or defects;



Oversee in-process activities, document acceptable and unacceptable observations, initiating an Incident Report when required, and provide summary reports to QA and Production Management, including but not limited to the following:







+ Clean Room Behavior and Aseptic Technique execution by personnel in all grades;



+ Aseptic Gowning observation and coaching for personnel entering the Grade A and Grade B areas;



+ Environmental Monitoring activities (in operation or at rest):



+ Facility Cleaning and Disinfection activities.







Be a reference point for manufacturing personnel and Supervisors on the shop floor.



Documenting/Recording Information - Entering, transcribing, recording, storing, or



maintaining information in written or electronic/magnetic form.



Perform Special Audit (Walkthroughs)



Investigate and resolve quality issues identified during Shop Floor Observation



Provide quality support of manufacturing and testing operations, reviewing documentation and assisting with investigations to ensure a quality product disposition



Work with Site Training Team to Identify the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.







**Qualifications**



At least 5 years of experience in an aseptic facility;



Experience in the Quality Operations organization;



Knolwedge of fundamental technical and quality concepts, applicable guidelines of the Regulatory Agencies and relevant Pfizer SOPs;



Proven Knowledge in problem solving techniques;



Thorough knowledge of global GMP requirements and expectations;



Have a well-balanced and strong GMP knowledge and good understanding of key processes/systems/equipment/utilities;







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Apply on the Company Site
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