Quality Associate I, Receiving & Inspection

This is whereyour 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

Quality Associate performs daily quality review of raw material documentation to ensure that materials being received are produced in accordance to Company methodology procedures and standards. Quality Associate completes Change Control Supplier Quality and Nonconformance and Corrective Action Preventive Action (CAPA) quality records related to Receiving & Inspection. Quality Associate is SME for Receiving & Inspection procedures and manages projects.

*** Thecandidate must not be allergic to Penicillin or Cephalosporin drugs

What youll Be Doing

• Reviews and approves documentation for API (Active Pharmaceutical Ingredients) Excipients Chemicals Laminated Rollstock Printed Direction Inserts Labels and Cartons.
• Provides Receiving and Inspection review support for materials purchased by Takeda.
• Manages raw material tracking log and scheduling work for R&I technicians.
• Manages RLDD Stability schedule and sends out Stability notices.
• Strong computer/software literacy preferred experience with material inventory management systems.
• Creates reassay and expiration report on a monthly basis.
• Completes GME and Labvantage setups for materials.
• Supplier Quality (SQ) responsibilities to include SCAR (Supplier Corrective Action Request) writing and review; Reduced testing of materials - new and periodic review; SQ approval of raw material part records; and Risk Action and Mitigation (RAM) review for Round Lake Drug Delivery.
• Owns and manages Change Control records.
• Performs investigations for R&I nonconformances and owns R&I related CAPAs.
• Performs R&I procedure and training code revisions in document system.
• Completes Certification of Documentation Review (CDR) process for raw materials to implement them in the plant systems.
• Validation and testing of computerized systems to include writing and executing a protocol.
• Submit and manage purchase orders in Coupa system.
• Manages quotes and sends samples to external testing labs.
• Complete and manage R&I Preventive Maintenance (PM) records in the Maximo system.
• Attends various Tier and Cross-Functional meetings as the R&I representative.
• Secondary responsibilities to support production as needed.
• Will work in both Drug Delivery and Penicillin facilities as needed.

What Youll Bring

• Associates Degree and one to three years of relevant experience required OR Bachelors degree and experience with a medical device/pharma or other similarly regulated industry preferred.
• Good writing and verbal communication skills and problem-solving skills are required.
• Ability to work in a team environment and make independent decisions based on procedural and regulatory requirements.
• Complete understanding of cGMPs and GDP procedures.
• 20/30 vision in at least one eye with or without corrective lenses.
• The candidate must be able to work flexible hours in a dynamic environment with minimal direct supervision.

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 - $93500 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors all of which are subject to change. Individual pay is based on 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.

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.

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