Associate II, Quality

Baxter•Marion, NC

35d•$80,000 - $110,000

About The Position

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 Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices. Your role at Baxter Leads ongoing, daily departmental operations. 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. Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary actions. 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. Serve as Subject Matter Expert (SME) 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. Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc. Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills Support process with timely closure of observations/audit items. Oversees audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.) Participate in QA/QC multi-site projects in the role of contributor, coordinator or lead. 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)

Requirements

BS in business/science or equivalent.
Minimum of 3 years of experience in Quality with a medical device/Pharma company or other similarly regulated industry.
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 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.
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.

Responsibilities

Leads ongoing, daily departmental operations.
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.
Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary actions.
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.
Serve as Subject Matter Expert (SME) 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.
Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills Support process with timely closure of observations/audit items.
Oversees audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.) Participate in QA/QC multi-site projects in the role of contributor, coordinator or lead.
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)

Benefits

Baxter offers comprehensive compensation and benefits packages for eligible roles.
Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

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