Sr Inspector, QA
- 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:
- 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.
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.
- 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.
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.