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Baxter International Inc. · 1 hour ago

Quality Lab Associate III - Sterility Assurance

Marion, North Carolina

Full-time

Onsite

Mid, Senior Level

$80K/yr - $110K/yr

5+ years exp

Baxter International Inc. is dedicated to redefining healthcare delivery and making a significant impact on patient lives. They are seeking a Quality Lab Associate III specializing in Sterility Assurance to ensure compliance with environmental monitoring and contamination control standards within manufacturing clean rooms.

BiotechnologyClinical TrialsHealth CareMedical

No H1B

Responsibilities

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 leads 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 thorough 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

Qualification

Environmental MonitoringMicrobiologyDocumentation PracticesSterility Assurance AssessmentsTrackWise Quality Management SystemAnalytical SkillsProblem-Solving SkillsProject Management SkillsCommunication SkillsLeadership Skills

Required

BS degree in Biology or Microbiology

Strong analytical and problem-solving skills

Ability to run multiple projects/investigations/priorities

Good communication and leadership skills

Good interpersonal/communication/influencing/negotiation skills

Good project management skills

Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings

Strong technical written skills

Preferred

Five (5) or more years of professional experience in Laboratory, Quality, Manufacturing, or related field is strongly preferred

Strong understanding of Environmental Monitoring programs, Microbiology concepts and Good Documentation practices is preferred

Detailed knowledge of applicable procedures, specifications, regulations, and standards

Knowledge of TrackWise Quality Management System

Benefits

Medical, Dental and Vision coverage

160 hours of Paid Time Off and Paid Holidays

401K match

Employee Stock Purchase Program

Paid Parental Leave

Tuition Reimbursement

Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance

Flexible Spending Accounts

Educational assistance programs

Paid holidays

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

The Employee Discount Program

The Employee Assistance Program (EAP)

Childcare benefits

Company

Baxter International Inc.

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For nearly a century, we have delivered on our commitment to saving and sustaining the lives of patients, working alongside clinicians and providers around the world.

Founded in 1931

Deerfield, Illinois, USA

10001+ employees