Quality Lab Analyst I: Microbiology & Cleanroom Testing

Zvh; United States; On-site; USD 68,000 - 94,000; Full time

Benefits offered by this job

Medical, Dental and Vision coverage

160 hours of Paid Time Off

401K match

Employee Stock Purchase Program

Paid Parental Leave

Tuition Reimbursement

Job summary

Baxter is seeking a qualified candidate to join the Quality team in an Environmental Monitoring role. You will perform microbiological testing on materials, in-process and finished products and operate lab instrumentation to collect data in a cGMP environment.

The role requires a B.S. in microbiology or related field, at least one year of pharma/medical device experience, and strong communication and project-management skills.

Qualifications

• 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.
• Proficient with core manufacturing and support systems.
• Computer literacy (Word, Excel).
• Must work well in a team-based environment.
• Familiar with FDA, cGMP, GDPs and TrackWise.

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 air sampling.
• Perform surface sample testing using plate and swab methods.
• Collect water samples throughout the facility weekly or monthly.
• Perform weekly and monthly HEPA inspections to ensure integrity of HEPA filters in clean rooms.
• Perform Real Time Risk Assessments to identify potential contamination issues.
• Review Environmental Events/Deviations and ensure documentation and testing are complete prior to approval.
• Develop joint relationships with Quality Operations/ Manufacturing/Engineering to initiate corrective actions.
• Sustain a clean and safe work environment applying 6S principles.

Skills

Communication

Project management

Microsoft Office

Interpersonal skills

Aseptic technique

Attention to detail

Education

B.S. in Microbiology/ Biology or related science

Tools

LIMS

TrackWise

Job description

Baxter is seeking a qualified candidate to join the Quality team in an Environmental Monitoring role. You will perform microbiological testing on materials, in-process and finished products and operate lab instrumentation to collect data in a cGMP environment.

The role requires a B.S. in microbiology or related field, at least one year of pharma/medical device experience, and strong communication and project-management skills.