Quality Lab Associate II – Sterility Assurance

Baxter International Inc. • Marion, NC

1d • $80,000 - $110,000 • Onsite

About The Position

The Quality Laboratory Associate II – Sterility Assurance is responsible for authoring, revising, and maintaining microbiology and sterility assurance GMP documentation, ensuring alignment with regulatory expectations, site practices, and global quality standards. This role supports contamination control, investigation readiness, inspection preparedness, and consistent laboratory execution through high‑quality, accurate, and compliant documentation.

Requirements

• Bachelor’s degree in Microbiology, Biology, Chemistry, Technical Writing, or related scientific discipline required.
• 5 or more years’ experience in a regulated pharmaceutical, medical device, or biologics environment.
• Experience with change management and document control systems required.
• Working knowledge of GMP documentation principles, regulatory expectations, and quality system requirements.
• Understanding of microbiology, contamination control, and laboratory quality systems.
• Demonstrated ability to work independently and make informed decisions with minimal supervision.
• Ability to evaluate documentation risks, determine appropriate corrective actions, and recommend sustainable solutions.
• Professional judgment in managing controlled documentation, interpreting regulatory requirements, and determining appropriate content revisions.
• Ability to influence SMEs and stakeholders to ensure accurate content ownership, timely reviews, and effective decision-making.
• Strong analytical and problem-solving skills with the ability to assess competing priorities and make risk-based decisions.
• Ability to identify compliance concerns and determine when escalation or additional review is required.
• Ability to meet deadlines in a fast-paced, regulated environment while balancing quality, compliance, and business priorities.
• Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Nice To Haves

• Previous experience writing or managing microbiology, sterility assurance, or manufacturing quality documentation strongly preferred.

Responsibilities

• Author, revise, and maintain microbiology and sterility assurance documentation, including: Standard Operating Procedures (SOPs), Work Instructions, Protocols and reports (EMPQ, validation, qualification), forms, templates, and controlled records.
• Evaluate existing documentation and determine appropriate revisions to ensure alignment with current processes, regulatory requirements, and quality system expectations.
• Interpret complex microbiology, contamination control, and laboratory practices and translate them into clear, accurate, compliant, and executable documentation.
• Collaborate with SMEs to assess documentation needs and recommend improvements that enhance compliance, efficiency, and laboratory execution: Bioburden, Environmental Monitoring, Identification, Lysate, Particulate Matter, Investigations, Sterility Assurance.
• Determine appropriate documentation strategies to support contamination control initiatives, inspection readiness, and operational consistency.
• Ensure documentation aligns with: cGMP, GDP, FDA, USP, ISO, and internal quality system requirements, site-specific contamination control strategies.
• Review and approve document changes within assigned authority levels, ensuring accuracy, consistency, and regulatory compliance.
• Support change control activities by evaluating the impact of proposed changes and coordinating documentation updates related to: CAPAs, investigations, continuous improvement initiatives, process or facility changes.
• Prioritize documentation activities based on business needs, compliance risk, investigation outcomes, and site objectives.
• Participate in cross-functional project teams and provide recommendations that support laboratory improvements, simplification efforts, and deviation reduction initiatives.
• Conduct independent reviews of microbiology documentation and determine document readiness for implementation, audit support, and regulatory inspection.
• Identify documentation gaps, compliance risks, and process vulnerabilities and make recommendations to mitigate potential execution errors or deviations.
• Support audits and inspections by: preparing documentation packages, leading or supporting document walkthroughs, providing documentation expertise during regulatory interactions.
• Establish and maintain document version control, consistency standards, and archival compliance requirements.
• Make recommendations to simplify, standardize, and improve documentation systems and practices to enhance effectiveness and reduce rework.
• Exercise sound judgment in resolving documentation issues, prioritizing competing requests, and escalating compliance concerns as appropriate.
• Sustain a clean and safe work environment utilizing 6S principles.
• Learn, understand, and apply rigorous quality standards, SOPs, and Current Good Manufacturing Practices (cGMP).

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
• basic life, accident, short-term and long-term disability, and business travel accident insurance
• Flexible Spending Accounts
• Employee Assistance Program (EAP)
• childcare benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level