Quality Lab Associate I - Environmental Monitoring (12pm-12am)

Baxter International Inc.•Marion, NC

3d•$68,000 - $93,500

About The Position

The Quality Lab Associate I supports Baxter’s environmental monitoring program by performing surface testing, viable air monitoring, air total particle counts, routine risk assessments, and HEPA filter inspections in clean rooms. The role conducts microbiological analyses on raw materials, in-process materials, and finished products, while ensuring timely testing, accurate documentation, data integrity, and compliance with local procedures and applicable regulations. The position also collaborates with Quality Operations, Manufacturing, and Engineering to address issues and initiate corrective actions. The listed shift is 12 p.m. to 12 a.m.; overtime is worked as required.

Requirements

Bachelor of Science degree in Microbiology, Biology, or a related science.
Strong communication and project management skills.
Knowledge of core manufacturing and support systems.
Computer literacy and knowledge of Microsoft Office applications, including Word and Excel.
Good interpersonal skills and ability to work effectively and efficiently in a team-based environment.
Proficiency in aseptic use and handling of media plates and swabs for environmental monitoring sampling.
Ability to work with minimal direction.
Attention to detail and strong organizational skills.
Basic understanding of laboratory instrumentation.
Good documentation skills and knowledge of Good Documentation Practices (GDPs).
Ability to manage multiple tasks and priorities in a timely manner.
Knowledge of aseptic technique and microbiological testing according to FDA, cGMP, GLP, and USP testing methodologies.
Ability to communicate effectively with supervisors and peers.
Authorization to work for an employer in the United States; the employer is unable to sponsor or take over sponsorship of an employment visa.

Nice To Haves

At least 1 year of experience in the pharmaceutical or medical device industry is preferred.
Familiarity with LIMS or an equivalent system and TrackWise.
Knowledge of FDA quality system regulations is preferred.

Responsibilities

Conduct microbiological analyses on raw materials, in-process materials, and finished products.
Use laboratory instrumentation and computer systems to collect and record data.
Complete routine and special-project or protocol testing in a timely manner according to local procedures and cGMP regulations.
Maintain data integrity and ensure compliance with regulatory agencies.
Operate SAS Air Sampler and Climet Particle Counter equipment to collect air and particulate samples.
Perform surface sample testing using plate and/or swab methods.
Collect water samples throughout the facility on a weekly or monthly basis.
Perform weekly and monthly HEPA inspections to verify the integrity of HEPA filters in clean rooms.
Perform weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in clean rooms.
Perform Instantaneous Microbial Detection (IMD) testing.
Review environmental events and deviations to verify documentation and testing are complete before submitting for approval.
Build working relationships with Quality Operations, Manufacturing, and Engineering to initiate corrective actions or work orders when issues are identified on the floor.
Maintain a clean and safe work environment using 6S principles.
Serve as a mentor to Quality Lab Technician (QLT) positions.
Work overtime as required.