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

Baxter International • Marion, NC

128d • $64,000 - $88,000

About The Position

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

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.

Responsibilities

• Support the environmental monitoring program by performing testing such as surface testing, viable air monitoring, and air total particle counts.
• 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.

Benefits

• Medical, Dental and Vision coverage starting on day one.
• 160 hours of Paid Time Off and Paid Holidays.
• 401K match.
• Employee Stock Purchase Program.
• Paid Parental Leave.
• Tuition Reimbursement.

What This Job Offers

• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree