Description
At Kelly® Science, Engineering, Technology & Telecom (SETT), we're passionate about helping you find a job that works for you. How about this one?
We're seeking an Product Quality Assurance (PQA) to work with one of our top global biopharmaceutical clients in the Barceloneta PR area. With us, it's all about finding the job that's just right
Purpose:
The Product Quality Assurance (PQA) Analyst has various objective/functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to approval of manufacturing direction to the production floor, review and approval of manufacturing, laboratory, and raw material investigations, assess product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. The PQA Analyst also is responsible to evaluate supplier change notification, monitor process track and trending, and perform annual Product Quality Reviews. This person also acts as a liaison between Customer regulatory areas and TPM plants for regulatory submission.
Responsibilities:
•Maintains an effective liaison and cooperative relationship with other Customer Areas including but not limited Quality, Regulatory, Technical, Supply Chain, along with the TPM sites.
•Ensures that bulk drug substance and/or drug product production at TPM sites is performed as per current good manufacturing practices, according to local procedures and as per specifications and manufacturing directions provided by Customer QA Operations.
•Ensures TPM procedures including but not limited to raw material specification, product specification, test methods, supplier change notification, shipping, are in compliance with cGMP, policies, regulatory approvals, and Quality Technical Agreement with TPM site.
•Review and approve manufacturing directions to the production floor.
•Provide support to PQA in global projects and events to ensure intended results are achieved; including planning, risk analysis, and implementation.
•Ensures investigations of TPM plant events related but not limited to process, laboratory, raw materials are completed thoroughly and documented accurately, including adequate product impact analyses and corrective and preventive action for plant events are documented. •Perform annual Product Quality Review according to Customer global procedure to comply with regulatory requirements.
•Participates in Trend Review Board to monitor process track and trending.
•Participates in the Global Change Review Board (GCRB) meeting as TPM representative to evaluate global changes related but not limited to supplier change notifications, process, laboratory, and regulatory submissions that impacts all sites.
•Generates detailed change management plans related to TPM plants changes to ensure intended results are achieved, including planning, risk analysis, and implementation.
Qualifications:
•Bachelor's degree preferably in Engineering or Science
•Six years of experience within the pharmaceutical operations, preferably Biologic manufacturing process
•Knowledge of GMP regulations and standards affecting pharmaceutical products •Comprehensive knowledge and application of business and quality concepts
•Strong analytical skills and attention to detail
•Change plan, Exception Reports, SAP and LRMS experience is highly preferred
•Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences
•Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization
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 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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