drjobs Sr QA Inspector, QM Lab

Sr QA Inspector, QM Lab

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1 Vacancy
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Job Location drjobs

Irvine - USA

Monthly Salary drjobs

$ 60000 - 75000

Vacancy

1 Vacancy

Job Description

This is where you save and sustain lives

At Baxter we are deeply connected by our mission. No matter your role at Baxter your work makes a positive impact on people around the world. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.

Baxters products and therapies are found in almost every hospital worldwide in clinics and in the home. For over 85 years we have pioneered significant medical innovations that transform healthcare.

Together we create a place where we are happy successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives where your purpose accelerates our mission.

Your Role At Baxter:

Responsible for endorsing process and product quality efficacy and safety through the routine assessment of plant operations and finished products. Responsible for ensuring adherence to the regulatory and procedural requirements that govern those operations and products.

Your team

When you join the Quality team you belong to a group that never shies away from a challenge and truly believes that teamwork makes jobs great. Motivated by work that is never the same from one day to the next this team powers through internal processes to create products that they deeply believe in. Individuals within the quality organization are encouraged to think strategically about how to best-solve any issues at hand. Baxter remains positive confident and resilient as it approaches new challenges and strives to create the best possible product for the client always.

What Youll Be Doing

  • Perform all tasks as QM Lab Technician with minimal supervision
  • Arrange and Conduct dose audits of final product with Vendor and Carrier.
  • Initiate and investigate exceptions/OOLs/NCR through TrackWise.
  • Perform laboratory and manufacturing audits as required.
  • Update plant SOPs as required.
  • Participate in functions involving teams which impact production increase efficiency tackle problems generate cost savings and improve quality.
  • Support improvement projects
  • Receiving purchased media and supplies.
  • Preparation and sterilization of reagents and media including growth promotion of media.
  • Sterilize tools and glassware for lab testing.
  • Collecting test samples in clean rooms and utility rooms.
  • Monitor the cleanroom environment (checking non-viable air quality assessing viable air quality evaluating viable surface conditions)
  • Monitor the environment of key systems like the compressed air and nitrogen system (non-viable and viable air)
  • Perform various laboratory tests on final product (bioburden and endotoxin testing)
  • Maintain data integrity and ensure compliance with company SOPs and specifications.
  • Documentation of tests on controlled forms or LIMS and maintain accurate and complete quality records.
  • Perform equipment maintenance as scheduled.

What Youll Bring

  • Knowledge of GMP documentation and FDA required.
  • Demonstrated attention to details and accuracy required.
  • Must have good communication skills.
  • General knowledge of quarantine and warehouse operation helpful.
  • May be required to work flexible hours and overtime on short notice.
  • Experience in a pharmaceutical or Biotech industry helpful
  • Familiarity with cGMP and FDA requirements preferred.
  • Bachelors Degree in science-related field with 0-2 years relevant experience OR
  • Associates degree in science-related field with 1-3 years of relevant experience OR
  • Highschool Diploma/GED with 5 years of relevant experience

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 our employees and we strive to be more transparent with our pay practices. To that end this position has a base salary range of $60000 to $75000. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including but not limited to relevant skills/experience time in the role business line and geographic/office location.

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.

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.

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:

Senior IC

Employment Type

Full-Time

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