Associate II, Quality at Baxter International

Marion, North Carolina, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

BS in business/science or equivalent
3-5 years experience in Quality with a medical device/Pharma company or other similarly regulated industry
Strong interpersonal skills and great attention to detail
Strong team player with good problem solving, and good verbal and written communication skills
Ability to manage people, encourage teamwork and drive decisions
Ability to handle multiple projects concurrently
Computer experience
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
Basic English written and oral communication skills adequate to communicate

Responsibilities

Provide 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
Lead ongoing, daily departmental operations
Supervise 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 (e.g., employee interviews, flow charting)
Work closely with production supervisors, quality, engineering and other internal groups to accomplish assessments 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
Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements
Participate in external assessments and audits by evaluating and solving product/process problems using technical, analytical and supervisory skills; support timely closure of observations/audit items
Oversee audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)
Participate in QA/QC multi-site projects in the role of contributor, coordinator or lead
Perform 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)

Skills

Quality Assurance

Regulatory Compliance

Risk Assessment

Internal Audits

Staff Supervision

Process Evaluation

Employee Training

Non-conformance Management

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

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