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. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s 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
This position reports to the Manufacturing functional areas. This position provides the Manufacturing documentation review. Review the batch record or any other GMP document to ensure the compliance with cGMP, Company Policies and local SOPs.
What you'll be doing
- Supporting manufacturing’s batch documentation review.
- Responsible for ensuring manufacturing’s batch records meet specifications and submitted to Quality per release schedule
- Assure batch documentation complies with GDP standards.
- Determine acceptability by using specifications and standard operating procedures.
- Ensure presence of all required documentation prior to the submission of batch folder to Quality.
- Maintain files such that documents are readily available and easily retrievable.
- Initiate and close GME work orders.
- Author Non-Conformance Records (NCRs) and Exceptions Investigations
- Author TCU documentation changes including revisions, periodic reviews and GAP assessments
- Use Maximo system to print department preventative maintenance work orders; assign and bring to completion, as necessary.
- Use SYSTECH to review and approve counts for batches.
- Initiate batch folders by performing necessary data entry.
- Support GME cycle counting as needed
- Other administrative duties as assigned.
What you'll bring
- Associates degree or 3+ years of experience in manufacturing environment and / or quality documentation.
- Strong computer skills in MS Office Suite.
- Knowledge of documentation systems and familiarity with batch/systems documentation preferred.
- Strong attention to detail.
- Individual will work with minimal supervision in a dynamic environment while following written procedures. Must be organized and able to prioritize tasks.
- Ability to communicate efficiently verbally and in writing with all levels of the organization.
- Identify areas for continuous improvement.
- Individual must be willing to adjust work hours and work overtime based on business needs.
- Must be able to lift 30 pounds.
- Must not be allergic to Penicillin or Cephalosporin drugs.
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 $48,000-$66,000 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. This position may also be eligible for discretionary bonuses. 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.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
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.
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