Quality Lab Associate I Environmental Monitoring (12pm-12am)
Baxter
This is where your work makes a difference.
At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou 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 its 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 youll 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 youll 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.
We understand compensation is an important factor as you consider the next step in your career. At Baxter we are committed to equitable pay for all employees and we strive to be more transparent with our pay practices. The estimated base salary for this position is $68000 - $93 500 annually. 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 on upon location skills and expertise experience and other relevant factors. For questions about this our pay philosophy and available benefits please speak to the recruiter if you decide to apply and are selected for an interview.
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. Financial and retirement benefits include the 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. We also offer 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 additional information regarding Baxter US Benefits please speak with your recruiter or visit our Benefits site: Benefits Baxter
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.
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.Recruitment Fraud Notice
Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself review our Recruitment Fraud Notice.Required Experience:
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