dcsimg
 

Stay up-to-date on Baxter careers

Apply Now    

Sr Inspector, QA

Req #: 180000M4_en
Location: Marion, NC US
Job Category: Quality
Date Posted: 1/16/2018 12:01:03 PM
Baxter International

Description

About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Description
Ensures through observation and corrective action that product quality, system adequacy, productivity and employee safety is maintained for the manufacturing operations: Plastics, Filling and Packing.  Manages the initiation, performance, review and closure of procedural, system and process assessments to assure regulatory adequacy and compliance.  Manages exception situations and documentation and is responsible for the outcome of actions taken and decisions made during production.  Manages the initiation and completion of quality improvements, value improvements, statistical and protocol validation projects for the manufacturing operations.  Manages quality trending database systems for the preparation of monthly/quarterly “quality trend.” Responsible for promoting the Quality Leadership Process and philosophy through team leadership and idea participation. 

Essential Duties & Responsibilities
  • Required to initiate, coordinate, perform and manage closure of equipment and process modification validation protocols.
  • Required to develop a complete understanding of computer software and systems to include:  word processing, spreadsheets, statistical, graphics and database management. Is required to instruct/train, where applicable,Employees on the use of items listed above.
  • Required to perform and manage assessments of processes, systems and   products.  Retrieves and gathers relevant information and data, reviews applicable procedures and specs, performs any necessary testing, prepares technical write-up of findings, generates conclusions and suggestions, communicates concerns and ideas of each item/concern noted.
  • Accountable for the outcome of actions taken and decisions made during production exception situations.  Exception document handling to include(Document Supplements, Product Retentions, In-process Retentions, Failure Investigations and Quality Impact Statements.
  • Performs and manages audits of quality and manufacturing processes, systems and products.   The senior technician must maintain updated knowledge of all relevant SOPs and Specs.  
  • Must perform routine manufacturing area audits in order to ensure the integrity and quality ofmanufacturing processes, systems and products.
  • Required to maintain and manage “Quality Trending” systems including: Leaker Analysis, Filter Failures, Packing Count Discrepancies, Plastics Subassembly reports and various quality trending data. 
  • Required to initiate and coordinate the completion of, when necessary, XPOs, filling experimental forms and packing experimental forms.
  • Required to perform final approval of manufacturing operations documentation to include:  labeling approval, manufacturing checks approval and quality audit chart approval.       
  • Required to perform daily and/or weekly checks.  Checks include but are not limited to:                                                         
Plastics: Machine Validation, establishing parameter limits, GMP  audits,product and measurement checks for membranes, Keifels, injection sites, extrusion, slush bag, system 111, amplas and additional processes as required.   Systems testing on parameters, logs and documentation.    
Filling: GMP audits, product and measurement checks for dies, printers, filling Machines.  Testing for particulate matter and filter integrity.  Systems testing for parameters, logs and documentation.                  
Packing: Product use testing, GMP audits, product and measurement checks for carton erectors, trucks, vision systems, case packers and direction sheet inserters.  Systems testing on parameters, logs and documentation. 
  • Required to perform training of manufacturing and or quality personnel as required. Manages quality department training manuals and reviews manufacturing training manuals. Initiates and/or coordinates any changes/updates.
  • Responsible for accounting, completeness and correctness of sampling procedures.  Required to understand and use sampling plans such as militarystandards, switching sampling and statistical/SPC.    
  • Required to perform calibration of equipment used for measurement including: cylinders, rulers, limit gauges and syringes.
  • Required to solve daily quality and equipment issues.  Responsible ford etermining and measuring the quality and releasability of the product. Required to understand product flow in order to determine product traceability and downstream effect of all decisions.   
  • Prepare and communicate to appropriate personnel including:  manufacturing operators, supervisors, managers, peers and plant visitors.  Maintain effective communication and social skills in order to interact with various plant departments.
  • Required to lead plant related teams such as:  QWTs, Ad Hoc committees,  PMTs.                                                        
  • Required to manage projects as assigned or self initiated.       
  • Required to assist with vendor audits and vendor certification.         
  • Required to manage, audit and approve standard operating procedures as a procedural “PRO.”                                               
  • Required to coordinate shift scheduling/staffing based  on available resources and activities.                              
  • Required to investigate, resolve and document final goods complaint issues as necessary.                          
MENTAL PROCESS              
Must be a self-motivated  individual which is performance motivated.  Must pay extreme attention to detail, prioritize and perform work with minimum errors in a timely manner.  Required to analyze and manage quality indicators in order to monitor manufacturing processes.  Accountable for assuring compliance with regulatory and procedural requirements.  Must be able to demonstrate leadership abilities. Must be able to converse and work well with various disciplines with the plant.

WORK ACTIVITIES         

The position involves lifting,  samples and  labels (25-50 lbs.)  Use of hand tools, calculator, scales (digital & manual), filters, rulers, graduated cylinders, syringes, measurement gauges (limit, roughness, pressure, snap, in-strong and taper), profilometer, chattilon, calipers, laser micrometer, displacement tester,  burst tester and microscopes.  Use of computers and computer software including, but not limited to, word processing, graphics , statistical, spreadsheets, forms and database trending systems.  Position requires team leadership, exception resolution and documentation, employee training, procedural development and implementation and protocol/experimental development completion.       

RELATIONS WITH OTHERS:

Provides direction to manufacturing operators, handlers and supervisors for interpreting information/data, investigating exception situations, choosing appropriate corrective action and following  regulatory and procedural requirements for systems, processes and products.  Coordinates operations with other technicians, as well as, quality management supervisors, superintendents and managers.  Requires interface with manufacturing operators, handlers, supervisors, superintendents, managers, chem lab personnel, specifications, engineering, calibrations, maintenance, documentation center and secretaries.  The senior technician will be required to interface with vendors, IPSO customers and visitors.

Qualifications

Qualifications for this role

Must have been an operations quality technician for a minimum of 1 year within the last 5 years with acceptable performance.


Additional Qualifications: 

  • Must not have an attendance Stage 2 warning within the previous 6 months.
  • Must not have had a written Stage 2 warning within the previous 6 months.
  • Must have good written and oral communication skills.
  • Proficiency in exception handling.
  • Familiarization with validation and extraordinary tests/evaluations.
  • Proficiency in assessment of practices to procedures.
  • Proficiency in leadership of teams and group activities.
  • Must have a good working knowledge in presentation skills and conveying ideas.
  • Proficiency in problem solving and analytical skills.

Education & Experience

  • Must have a high school diploma or equivalent.  Associate Degree preferred.     
  • Must have successfully completed the Baxter Technician Certification training

A Career that Matters

Baxter's employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.


Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.


EEO is the Law

EEO is the law - Poster Supplement

Pay Transparency Policy


Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.

Apply Now    
Link for schema