Quality Assurance Specialist
OkloSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Medical Devices, ManufacturingIndustries
Requirements
- Bachelor's degree in science or engineering required. Advanced degree in the life sciences, physical sciences or engineering preferred
- Minimum of 5 years of quality experience in pharma, medical device or related field preferred
- Strong communication and interpersonal skills and great attention to detail
- Strong project management skills
- Working knowledge of FDA Regulations and Application of Good Manufacturing Practices (cGMP) and Good Documentation Practices
- Knowledge of FDA quality systems regulations, preferably experience interacting with FDA or similar regulatory agencies
- Good analysis, troubleshooting, and investigation skills including knowledge and understanding of problem-solving methodologies (e.g. DMAIC, Fishbone Diagram)
- Ability to write, review, and revise Standard Operating Procedures (SOPs) and process changes, and submit procedural changes to meet Corporate, Divisional, Plant, and Regulatory Requirements
Responsibilities
- Consider Safety of themselves and others as first and foremost
- Manage, oversee, track and drive accountability of all active projects in Cell 2 Quality
- Interact with other global Baxter facility representatives (IPSO customers) that North Cove (Cell 2) supplies product to when quality issues arise. Work with Cell 2 Manufacturing to resolve these quality issues collaboratively
- Own, coordinate or lead multiple projects consecutively while performing other required job duties. Work with corporate teams when needed
- Manage/oversee the department monthly and quarterly trends. Make improvements to trending as needs and requirements change
- Become a resident SME of plastics areas. 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
- When required, assist other Quality areas in the successful performance of these activities
- Perform the duties of the Cell 2 Quality Manager when needed. Run the Cell 2 Quality department on a daily basis when the manager is not available
- Cover the daily tasks and exceptions as they happen on the floor and oversee QT’s when floor QA is out
- Other duties, tasks or projects as assigned
Skills
Quality Management
Project Management
Regulatory Compliance
Plastics Expertise
Trend Analysis
Training and Coaching
Manufacturing Oversight
SME
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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