Sr Quality Assurance Scientist

Kelly® Science & Clinical is seeking Sr Quality Assurance Scientist for a 6 month contract position at a Global Pharmaceutical client in Manati, Puerto Rico. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Salary: $38.55 per/hour

Overview

This client is Global Biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

In this role you'll be responsible for assuring that the manufacturing and/or support areas operations (Sterile, Non-Sterile, QC Laboratories, Warehouse, Engineering, Supply Chain, MS&T, IM, among others) are performed in compliance with domestic and international cGMP regulations, and company policies and procedures and for providing scientific approach and Quality assurance direction to the approval of the GMP documents such as batch records, forms, protocols, procedures, qualification, and validation reports.

This role will give you an opportunity to transform patients' lives through science by contribute with a global leading biopharma company powered by talented individuals who drive scientific innovation .

Schedule: Work irregular hours, rotative shifts, weekends and holidays when needed.

Responsibilities:

• Enforce critical analytical thinking in the investigation management process specifically during root cause analysis, risk assessment evaluation and corrective and preventive actions determination to guarantee that gaps are properly addressed.

• Leads and participates in the critical review of all documents associated with the manufacturing and/or support areas operations, release, packaging and relevant activities in the operations areas.

• Ensures that deviation on documentation dealing with OOS or process parameters outside filing or validation are investigated and resolved by thoroughly reviewing timely corrective actions.

• Provides key technical guidance and oversight to manufacturing and/or support areas operations areas (Sterile, Non-Sterile, QC Laboratories, Warehouse, Engineering, Supply Chain, MS&T, IM, among others to assure the appropriate cGMPs are in place through quarterly, monthly, weekly, or daily operations audits, as applicable.

• Ensures compliance of all procedures (SOP's) to avoid potential regulatory and compliance issues; including GDP and electronic systems compliance.

• Provides scientific input into investigations management to assure root cause and CAPAs are aligned with the opportunities identified in order to perform a systematic approach.

• Supports actively the investigation processes in manufacturing areas (Sterile and Non Sterile) and support areas such as Warehouse, QC laboratories, IT, MS&T, facilities and utilities providing coaching from Quality perspective.

Qualifications:

• Bachelor Degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology) with six (6) years of experience in Quality Assurance responsibilities in a pharmaceutical industry, or Doctoral Degree (PhD) in Pharmacy with valid License in Pharmacy (Good Standing and / or without Restrictions of Puerto Rico Board of Pharmacy).

• Knowledge of manufacturing operations of Oral Solid Dosage and Parenteral Products Manufacturing.

• Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use.

• Fully bilingual (Spanish/English) communication skills, both written and verbal.

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 (~~~) 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.