QA Auditor- Parenteral Job Listing at Kelly Services in Gurabo, Gurabo (Job ID 10132135)

Description

Join Kelly Services as a QA Auditor Parenteral – Gurabo, PR
At Kelly Services, we're passionate about matching talented people with roles they love. How about this opportunity?
We're seeking a QA Auditor Parenteral to join one of our top clients in the pharmaceutical industry in Gurabo, PR. With Kelly, it's all about discovering the job that's just right for you! Job Summary The QA Auditor Parenteral is responsible for ensuring that products and services meet established standards of quality, including reliability, usability, and performance. Essential Job Duties and Responsibilities

• Perform and document process and facility quality audits in Parenteral Manufacturing and Utility Areas according to established procedures, cGMP, and Company Standards.
• Evaluate process and facility audit findings; ensure corrective actions are implemented appropriately (in collaboration with supervisor).
• Coordinate and conduct AQL inspections of finished Parenteral Products; monitor testing and inspection of materials/products to ensure quality standards are met.
• Review batch records, in-process documents, analytical data, and other regulatory documentation for compliance with procedures, cGMP, and Company Standards.
• Ensure batch records, in-process documents, analytical data, and checklists are filed in an organized and easily retrievable manner.
• Collect and compile statistical quality data as requested by the QA Supervisor.
• Review and/or approve SOPs, Work Instructions, and Forms for Quality Assurance, Manufacturing, and Engineering using the Docspace System.
• Perform SAP transactions to maintain good inventory practices for Parenteral Manufacturing Materials in compliance with procedures, cGMP, and Company Standards.
• Promote a safe environment by ensuring equipment and process designs comply with our company quality and safety procedures as well as local/national regulations.
• Assure all related product samples are collected as per batch record requirements.
• Support the Quality Assurance Sr. Supervisor to drive quality and personnel objectives aligned with Company and QA Department goals.
• Provide compliance support to Manufacturing and Packaging Operations to assure execution in compliance with cGMPs, our Company Global Standards, Company Policies, Quality Agreements, Batch Records, and current procedures.
• Evaluate current operating procedures and recommend process improvements to management.
• Prepare reports to communicate the outcomes of quality activities (e.g., Shift Reports, Documentation Error Trending Reports).
• Complete required training in Compliance System within specified due dates.
• Conduct activities related to quality indicators to improve the batch record documentation process and assure compliance with regulatory agencies and our company Standards.
• Provide QA support for complaint investigation reviews and change control related to processes.

Education & Experience

• Minimum of a Bachelor's Degree in Science required; major in Microbiology, Biology, Chemistry, or related field preferred.
• Flexible and available for first shift for initial training, and to be assigned to 2nd and/or 3rd shift (including weekends).

Assignment Details

• This is a maternity leave cover position with an approximate duration of 9–12 months

Why Kelly?

• Expansive Network: Gain access to a variety of career opportunities with our vast network of client companies.
• Guidance & Support: Benefit from career resources and tools for every stage of your professional journey.
• Training: Free access to over 3,000 online courses via our Kelly Learning Center.
• Benefits: Weekly pay, Holiday, Sick & Vacation paid time, plus a Christmas bonus!*
• More Opportunities: Stay in our network for future roles, even if this one isn't a perfect fit.

Ready to Discover What's Next? We're excited to help you take the next step. Apply today to become a QA Auditor Parenteral with Kelly Services in Gurabo, PR!
*Must meet minimum requirements to qualify for benefits.

 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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