Quality Assoc I - Documentation Center
Req #: 180000TJ_en
Location: Marion, NC US
Job Category: Quality
Date Posted: 1/8/2018 5:42:10 PM
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.
Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities. This role will coordinate/support Batch Release activities.
Essential Duties & Responsibilities
- Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.
- Coordinates ongoing, daily batch release departmental operations and performs reviews in all batch release areas as back-up capacity.
- Ability to enter and trend all tier 1 exceptions into the Infinity Trending System with accuracy.
- Prepare Certificates of Analysis as required per customer quality agreements on an as needed basis.
- Ability to work alone and correctly prioritize work load by determining areas of criticality for doc center review to meet customer requirements and needs as well as business needs and commitments.
- May act as the backup to the Batch Release Supervisor/Manager.
- Perform final review of completed systems or process documents such as distilled water system, compressed air system, compressed nitrogen system, environmental control, production process records and steam sterilization for acceptability per specifications and checklists. Must release system documents daily. Must follow strict guidelines per specifications, SOPs, and MDM's. Make decisions regarding documentation issues. Incumbent must ensure all support documents and correct signatures are present before releasing systems. Must plan own workload releasing and reviewing of system documents by priority.
- Perform final review of test results for completeness and assurance that product is within limits of specifications. Perform final review of filling and packing production documents which are issued from the BFR (batch folder release) system per MDM's. Read bill of material and temporary substitutions to assure correct parts have been used.
- Perform final review of sterilization charts, records, and graphs to assure product has been sterilized by the correct specifications. Use controlled templates to evaluate cycle parameters.
- Accumulate all required documentation for a batch and perform crosschecks on documents with a specific batch. Enters data in a computerized batch release system to log documents and provide a checklist of required documentation for each batch prior to release. Releases batch in required computer systems (Batch Release System, Compass, and JDE Systems).
- Must be able to prepare graphs, charts, and reports via Batch Tracking System, Microsoft Word and Microsoft Excel. Must be able to prepare material for meetings, resolve issues with Supervisors to assure acceptability of product. Incumbent receives general supervision. Interact with peers, production, QM Superintendents, supervisors, chemists, technicians, QM Manager, Plant Manager, sterilizer operators and Maintenance.
- Ability to use formula to verify percent yield calculations; defect per million calculations and accountability calculations. After calculations are verified must be able to recognize out of limit conditions and assure actions are taken.
- May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; Interview/hire, evaluate, train and develop direct reports
- Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
- Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.
- Determine the logic, adequacy and effectiveness of processes, systems and related requirements.
- Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.
- Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
- Provide departmental metrics and analyze for corrective/ continuous improvement actions.
- Support external assessments or audits. Assist with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)
- Serve as Subject matter Expert (SME) and provide training to local employees as needed on relevant area(s) Other duties, tasks or projects as assigned. Sustain a clean and safe work area using 6S principles
- Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
Qualifications for this role
- Strong interpersonal skills and great attention to detail are necessary.
- Must be a strong team player with good problem solving, and good verbal and written communication skills.
- Must have the ability to manage/influence people, encourage teamwork and drive decisions.
- Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate
- Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
- Must have basic English written and oral communication skills adequate to communicate with other team members.
- Must be able to organize workload and prioritize tasks while working in an environment that requires team work and flexibility.
Education & Experience
Bachelor's degree required or equivalent experience . Degree in the life sciences preferred.
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.