Quality Associate II - Onsite Weekdays

We need to output HTML fragment with headings

for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. Must not include Job ID etc. Must preserve all substantive info, remove boilerplate, navigation, legal, EEO, scam warning, duplicated lines, application instructions. We need to parse the posting. Key content: - Intro paragraph about Baxter mission etc. Could be "About the role"? Actually "Your role at Baxter" maybe part of description. The instruction: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need to decide which sections to include based on content. We have: - Description of role: "Your role at Baxter The Compliance & Records Management, QAII is responsible for site QA Compliance, Internal/External Audits, Site Audit Readiness and all aspects of hosting Audits, Regulatory Intelligence (GOC), Management of the Global Entity review and Periodic Review processes, QA site Model, and other Quality System items as assigned." That's a paragraph describing role. Could be "About the role". We'll put that under

About the role

with

. - Responsibilities: The "What You'll Be Doing" section lists many responsibilities. Also "Records Management:" sub-section. So we can put under

Responsibilities

with

• items. - Requirements: "What You'll Bring" includes Bachelor's degree required, MS a plus, minimum 3+ years experience, etc. That's qualifications/requirements. Could be split into Requirements and Qualifications and Skills. But we need to decide based on content. We have: - Bachelor’s degree required. MS in science/engineering a plus. - Minimum of 3+ years of experience in Quality with emphasis on oversight of regulation and compliance, or related field with a medical device/pharmaceutical company or similar regulated industry, preferred. - Must be experienced with interpreting quality system regulations. - Audit experience is preferred. - Working knowledge of Quality Systems and related requirements and standards, including 21 CFR Part 820, ISO 13485, preferred. - Knowledge of risk management, root cause analysis, corrective and preventive action and document control. - Demonstrated use of quality and root cause analysis tools, principles, and methodologies including statistical tools. - Proficient with computers and in the use of Microsoft Office Suite. - Strong verbal / written communication skills, problem solving and personal conflict resolution skills. - Strong attention to detail with the ability to independently organize workload, perform under strict deadlines and changing priorities with minimal supervision. - Project management skills and must be able to handle multiple projects concurrently. - Ability to communicate with all levels within the organization. - Able to demonstrate responsiveness to customer needs, within job scope. - Knowledge of Food & Drug Administration (FDA) Regulations and application of Good Manufacturing Practices. - Comprehension of design methodology, product configuration and complex manufacturing processes. - Ability to excel in a team-oriented environment. These could be split into Requirements (education, experience) and Qualifications (knowledge, skills) and Skills (specific abilities). But we can combine into sections as appropriate. The instruction: Prefer a few substantive sections over many thin ones. So maybe we combine Requirements and Qualifications into one section? But they gave examples of possible headings. We need to include a section only when posting has real specific content for it. We have content for Responsibilities, Requirements (education/experience), Qualifications (knowledge/skills), Benefits, Pay, Schedule. We have location and schedule: "Important: This position is located in Medina, NY and is designed as an onsite role, with an encouraged presence of five (4) days per week to foster collaboration..." That's schedule info: onsite, encouraged presence five (4) days per week (typo maybe 5 days). So we can include Schedule section. We have Pay: "The estimated base salary for this position is $ $88,000-$121,500 annually." So we have Pay. We have Benefits: "US Benefits at Baxter (except for Puerto Rico) ..." includes health, dental, ESPP, 401(k), FSA, educational assistance, time-off benefits, commuting benefits, etc. So Benefits section. We also have "Physical Demands" and "Work Environment" but those are not in the list of headings; we could drop them as they are not requested headings. However we must preserve ALL substantive information; but we can only use allowed headings? The instruction: Use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but says use those for section headings. It might be okay to include other headings if needed, but better to stick to those. However Physical Demands and Work Environment are substantive; we could incorporate them into Responsibilities or maybe a separate section like "Working Conditions" but not in list. Could we omit them? The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. So we need to include that info somewhere. We could add a

  Working Conditions

  but not in the list; but they gave examples, not exclusive list. It says "Use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." The "e.g." suggests those are examples, not limited. So we can add other headings if needed. But to be safe, we could incorporate Physical Demands and Work Environment into Responsibilities or a new section like "Work Environment". However the instruction says Prefer a few substantive sections over many thin ones. So maybe we add a section "Working Conditions" with those details. But we also have location info; we could put location under About the role or Schedule. Let's plan sections: - About the role: intro paragraph about Baxter mission and role description. - Responsibilities: bullet list of duties (What You'll Be Doing + Records Management). - Requirements: education and experience (Bachelor's degree required, MS a plus, 3+ years experience, etc.) - Qualifications: knowledge of regulations, standards, tools, etc. (maybe combine with Skills) - Skills: communication, attention to detail, project management, teamwork, etc. - Benefits: benefits description. - Pay: salary range. - Schedule: location and onsite expectation (Medina, NY, onsite, encouraged presence 4-5 days per week). - Working Conditions: Physical Demands and Work Environment. We need to ensure we don't repeat info. Let's extract details precisely. First, About the role: combine the introductory paragraph about Baxter mission and "Your role at Baxter". The posting starts: "This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your role at Baxter The Compliance & Records Management, QAII is responsible for site QA Compliance, Internal/External Audits, Site Audit Readiness and all aspects of hosting Audits, Regulatory Intelligence (GOC), Management of the Global Entity review and Periodic Review processes, QA site Model, and other Quality System items as assigned." We can keep that as About the role. Responsibilities: The "What You'll Be Doing" bullet list (though it's paragraph sentences). Also Records Management sub-section. Let's extract each responsibility as a bullet. From "What You'll Be Doing": - Ensure compliance with Regulations and corporate processes such that desired business results are achieved. - Develop and sustain the Quality Management System in line with the required regulatory and industry standards (ISO 13485) and business requirements. - Understand and ensure conformance to regulations per FDA Quality System Regulation (21CFR Part 820), ISO 13485:2016, Canadian Medical Devices Regulations SOR/98-282, as well as Baxter Global Policies and Procedures applicable to elements of the Quality System. - Manage site certifications, external registration requirements. Liaise with external bodies on matters relating to registration. - Manage various aspects of the audit lifecycle including planning, scheduling, notification, executing, hosting, issuing reports, evaluating responses, requesting clarifications, issuing and closing CA/PA’s. This may include qualification of Site internal auditors. - Write, review, analyze and revise Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc. - Serve as Subject Matter Expert (SME) in Quality compliance by maintaining a high level of expertise in current regulatory requirements. Provide training and coaching to local employees and others as needed on relevant area(s). When required, assist other quality areas in the successful performance of these activities. - Lead Audit Readiness efforts for the site and ensures compliance to regulatory requirements. - Manage the site Internal Audit Program, participate in audits and/or qualify/oversee alternate Site auditors, plans for corrective and preventive actions related to internal audit findings or gaps identified in the QMS. - Manage Site Compliance programs such as Global Observation Certification, Global Entity Review, and Periodic Review. - Strategize quality improvement activities in collaboration with other departments. - Manage activities of self in achieving defined quality goals in an efficient, accurate and timely manner. - Provide detail analysis of the QMS KPIs for management review meetings and other platforms as needed. - Balance cost, quality, people, and delivery objectives to meet plant goals utilizing standard enterprise management system. - Ensures KPIs are met by working to overall plan, including management of, and reporting. - Support in failure investigation activities (CAPA projects) to identify the root cause, develop appropriate corrective/preventive actions and approve CAPA’s, NCR’s. - Other duties, tasks or projects as assigned. Records Management: - Maintaining an inventory of stored Records, ensuring Records are indexed and tracked for ease in retrieval, managing Records submitted to and/or stored with third party storage suppliers and evaluating Records to determine their destruction eligibility. - Maintain an inventory of stored Records - Ensure Records are indexed and tracked for ease in retrieval. - Ensure Records are archived/stored in appropriate locations (both electronic and physical). - Track storage submissions and retrieval activities for records submitted to and/or stored with offsite storage providers. - Monitor/adhere to Legal Hold Orders - Annually evaluate Records to determine their destruction eligibility. - Periodically (at least annually) review trigger dates to enter known dates that have occurred. - Prepare and route destruction eligibility reports/lists for review by Functional Leaders - Upon approval, destroy Records in a timely fashion in compliance with Baxter’s policies and procedures. - Other duties, tasks or projects as assigned. We can combine duplicates: some bullet points repeat. We'll deduplicate. Now Requirements: Education and experience. - Bachelor’s degree required. - MS in science/engineering a plus. - Minimum of 3+ years of experience in Quality with emphasis on oversight of regulation and compliance, or related field with a medical device/pharmaceutical company or similar regulated industry, preferred. - Must be experienced with interpreting quality system regulations. - Audit experience is preferred. Qualifications: Knowledge of standards, tools, etc. - Working knowledge of Quality Systems and related requirements and standards, including 21 CFR Part 820, ISO 13485, preferred. - Knowledge of risk management