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 Quality Assurance Specialist (Batch Record Review) 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
Maintain custody of batch records and support data audited in the document control area.
Facilitate batch record documentation during internal and external inspections. The Audit Technician is responsible for the approval and release of manufactured/packaged products.
Review and audit the batch records for production areas. The audit process includes checking material consumption, environmental conditions, evaluation of critical parameters, cleaning, printed material usage, expiration dates. The review and audit may be conducted at the production areas on-line based to business needs.
Identify and address timely correction of discrepancies observed during the batch record review following cGMPs and documentation practices. The auditor is responsible for evaluating the discrepancies and to contact the SME for resolution.
Evaluate and approve the exceptions generated during the manufacturing and/or packaging process. Also, responsible for obtaining the supporting data to approve and close Hold documents.
Provide final disposition of drug products, components, raw materials, and finish products as applicable.
Create or verify certificates of analysis, compliance or manufacture for products as required.
Keep manual or electronic tracking of documents processed and those pending review. Be the custodian for documents in a controlled area and facilitate internal or external requests. Prepare applicable documentation packages for record retention.
Has the knowledge and utilize electronic systems to review inventory transactions and provide disposition (e.g. SAP), exception documents (e.g. Soltraqs), and electronic manufacturing batch records (e.g. POMsNet) among others.
Generate and provide reports to area supervisor or management upon request. File batch record
documentation after receiving and/or approval and generate the associated documentation of this process.
Responsible for performing tasks assigned based on identified business area needs.
May be required to perform quality control inspections, verifications and documentation review for
manufacturing or finishing areas as required.
Qualifications :
Associate or Bachelor Degree in Science
Experience in Quality Control in a pharma related industry. Experience in batch records audit (preferred)
Knowledge of GMPs, DEA controlled substances handling (preferred)
Able to perform basic math operations and to handle documentation using electronic systems
Good verbal and written communication skills (English and Spanish)
Daily Work Schedule Expectations Shift 10-6PM – Tuesday to Saturday
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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