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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
Job Responsibility:
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 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
Performs weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in clean-rooms
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
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
Serve as mentor to Quality Lab Technician (QLT) positions
Able to communicate optimally with supervisors and peers
Knowledge of FDA quality system regulations is preferred
Applicants must be authorized to work for an employer in the U.S.
We are unable to sponsor or take over sponsorship of an employment visa at this time