Kelly® Science & Clinical is seeking Specialist QA * for contract position at Pharmaceutical client in *Puerto Rico East area.

FUNCTIONS

• Review and approve product MPs.

• Approve process validation protocols and reports for manufacturing processes. - Request Quality on incident triage team.

• Approve Environmental Characterization reports.

• Release of sanitary utility systems.

• Approve planned incidents.

• Represent QA on NPI team.

• Lead investigations.

• Lead site audits.

• Own site quality program procedures.

• Designee for QA manager on local CCRB.

• Review Risk Assessments.

• Support Automation activities.

• Support facilities and environmental programs.

• Review and approve Work Orders.

• Review and approve EMS/BMS alarms.

• Approve NC investigations and CAPA records.

• Approve change controls.

• Provide lot disposition and authorize lots for shipment.

EDUCATION/ REQUIREMENTS

• Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related

-Candidates must be available for a 12 hrs. shift AM or PM, including weekends and Holidays.

COMPETENCIES/SKILLS

• Project management skills.

• Strong organizational skills, including ability to follow assignments through to completion.

• Initiate and lead cross functional teams.

• Enhanced skills in leading, influencing and negotiating.

• Strong knowledge in area of expertise.

• Collaborate and coordinate with higher level outside resources.

• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.

• Demonstrate ability to interact with regulatory agencies.

• Strong word processing, presentation, database and spreadsheet application skills.

• Strong communication (both written and oral), facilitation and presentation skills.

• Strong skill in working independently and to effectively interact with various levels.

• Advanced data trending and evaluation.

• Ability to evaluate compliance issues.

• Demonstrate the Amgen Values/Leadership Practices.

What happens next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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.