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

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

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.

Your Role at Baxter

This is where your creativity addresses challenges Supports the environmental monitoring program by performing testing such as surface testing, viable air monitoring, and air total particle counts. Responsible for conducting routine risk assessments and HEPA filter inspections in clean-rooms.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation. The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

What we offer from Day One

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

What you'll be doing

• 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.
• 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.

What you’ll bring

• 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.

The estimated base salary for this position is $68,000 - $93, 500 annually.

At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors.

Other Duties as Assigned

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.

• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

Join us and enjoy the competitive compensation and benefits we offer to our employees.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights

Workplace Discrimination is Illegal. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Our Mission to Save and Sustain Lives

This is where you belong.