Quality Lab Associate III - Sterility Assurance at Baxter
Marion, North Carolina, USA -
Full Time


Start Date

Immediate

Expiry Date

07 Sep, 25

Salary

80000.0

Posted On

07 Jun, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Pharmaceuticals

Description

THIS IS WHERE YOU SAVE AND SUSTAIN LIVES

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

Responsibilities

WHAT YOU’LL BE DOING

  • Author and complete Environmental Monitoring Performance Qualifications (EMPQ) related to the manufacturing clean/classified rooms in compliance with local and regulatory requirements
  • Coordinate sampling activities with EM sampling team and manufacturing department as applicable
  • Perform Failure Modes and Effects Analysis, as needed
  • Prepare and present to management the trend reports related to EMPQ and contamination control activities
  • SME of EMPQ and contamination control aspects providing leadership, technical and quality support to manufacturing and during regulatory inspections or site audits
  • Understands and assures conformance to regulations
  • Works with regulators during regulatory inspections
  • Interacts frequently with functional peer group and managers, as appropriate
  • Identifies and manages continuous improvement projects with the objective of achieving quality, reliability, and cost improvements
  • 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). Author and revise Standard Operating Procedures as needed.
  • Review and approve EMPQ and contamination control procedures, protocols, and reports
  • Perform Sterility Assurance Assessments as part of the Change Control Management process
  • Assist in establishing response plans to environmental out of limits
  • May be asked to lead classroom-based training for new employees and continuous education classes for established employees

OTHER DUTIES AS ASSIGNED

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. To that end, this position has a salary range of $80,000 to $110,000 and also includes an annual incentive bonus. The above range represents the expected salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

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