Quality Lab Associate I - Environmental Monitoring (7pm-7am)

Baxter International Inc.•Marion, NC

3d•Onsite

About The Position

This role supports the environmental monitoring program by performing various testing procedures, including surface testing, viable air monitoring, and air total particle counts. The associate is responsible for conducting routine risk assessments and HEPA filter inspections within clean-room environments. Within the Quality department, every role contributes to Baxter's mission of saving and sustaining lives by ensuring the quality of products shipped worldwide to patients in need. Individuals in Quality are empowered to use creativity to solve challenges and overcome production hurdles, with their work impacting global operations. The company's mission to save and sustain lives is paramount, prioritizing quality over quantity in all decisions.

Requirements

B.S. degree in Microbiology, Biology, or related science.
Minimum 1 year experience in Pharmaceutical/Medical Device industry preferred.
Strong communication and project management skills.
Possess knowledge of core manufacturing and support systems.
Computer literate/knowledge of Microsoft office applications (Word, Excel).
Must have good interpersonal skills and able to work optimally and efficiently in a team-based environment.
Proficient in the aseptic use and handling of media plates and swabs for EM sampling.
Must be a dedicated individual who requires minimal direction.
Attention to detail and strong organizational skills.
Must have a basic understanding of laboratory instrumentation.
Good documentation skills and knowledge of GDPs (Good Documentation Practices).
Able to manage multiple tasks/priorities in a timely manner.
Knowledge of aseptic technique and microbiological testing according to FDA, cGMP, GLPs and USP testing methodology.
Familiarity with LIMS (or equivalent system) and TrackWise.
Able to communicate optimally with supervisors and peers.

Nice To Haves

Knowledge of FDA quality system regulations is preferred.

Responsibilities

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