Quality Associate I

Baxter International Inc.-posted 2 months ago
$64,000 - $85,000/Yr
Full-time • Entry Level
Skaneateles, NY
5,001-10,000 employees
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This position is responsible for areas of the Quality System. Identify and assess regulatory and quality risk in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices. This position manages and maintains the day-to-day change control process, risk analysis reviews for processes related information within their assigned site. The position also has responsibility to work closely with various managers at the facility to monitor, manage and maintain a central computerized change control database of all employees at the facility.

  • Ensures efficient processing of change management for the Quality Management System in Trackwise.
  • Maintain Quality Metrics for change control timeliness and makes recommendations for improvement.
  • Leads and maintains all Management Review activities for the site.
  • Ensures documents of external origin (e.g., Regulations and Standards) are identified and evaluated for impact to the organization.
  • 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.
  • Identifies areas for process/quality improvements and supports those efforts.
  • Writes and publishes risk analysis for products for both the site level and to the corporate team for feedback.
  • Follows Good Documentation Practices (GDP) and ensures compliant documentation related to area of responsibility.
  • Conducts approvals of change requests, supplier change requests, validations, and coordination for escalation of change requests for deviations.
  • Associate Degree in business/scientific discipline required.
  • Bachelor’s Degree in the life sciences and experience with a medical device/pharma or other similarly regulated industry preferred.
  • 1-3+ years of relevant experience.
  • Strong interpersonal skills and great attention to detail are necessary.
  • Must be able to handle multiple projects concurrently.
  • Have strong knowledge of FDA Regulations, Application of Good laboratory Practices, and Application of Good Manufacturing Practices.
  • 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.
  • Medical and dental coverage that start on day one.
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount.
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
  • Flexible Spending Accounts.
  • Educational assistance programs.
  • Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
  • Family and medical leaves of absence.
  • Paid parental leave.
  • Commuting benefits.
  • Employee Discount Program.
  • Employee Assistance Program (EAP).
  • Childcare benefits.
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