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 for QA Technical Services Specialist to work in Barceloneta, PR. With us, it's all about finding the job that's just right
Purpose:
The QA Technical Services Specialist is responsible for QA batch record review and disposition assuring that bulk and finished products batch record documentation complies with Customer policies, regulatory requirements and current Good Manufacturing Practices. The function ensures the plant products meet specifications and quality requirements. This will require interaction with other Quality Assurance, Production, Engineering, IS and Administration personnel. The batch record review encompasses manufactured batch records, investigation of deviations, exceptions and nonconformance reports.
Responsibilities:
•Audit API and/or finished Drug Product electronic and manual (paper) batch records to assure
compliance with applicable GMPs, policies, procedures and guidelines.
•Evaluate potential discrepancies detected in batch records and determine the need for a corrective
action. Approve MES exceptions related to production support.
•Track/trend batch record discrepancies per procedural requirements and work with other
departments to evaluate the discrepancies to establish necessary actions to reduce errors.
•Give timely disposition to manufactured products in the SAP system based upon result of testing and compliance with Regulatory Agency requirements. Prepare Certificate of Analysis, Certificates of
Compliance for API and/or finished Drug Product.
•Enter and verify batch information into the lot restriction management system.
•Assemble the batch record review package and label per the approved retention procedures.
•Prepare reports related to Right the First Time, Release Cycle Time, Regulatory Audit requests and
Product Quality Review. Revise procedures as required.
•Coordinate and participate in plant weekly meetings for Shop Floor Control to discuss batch record
status including discrepancies and/or issues that may impact batch release.
•Demonstrates accountability and responsibility of EHS performance and compliance.
Qualifications:
1. Bachelor's degree in science preferably in Biology, Chemistry, Biotechnology or Engineering.
2. Knowledge and experience in manufacturing of biotechnology products is needed and in aseptic processing is preferable. Knowledge of Quality regulations and standards affecting chemical, biological or medical devices (i.e. Quality Systems, FDA regulations, etc.)- 2 years
3. Experience in batch record review audit process.
4. Experience in the interaction with Quality Assurance, Production, Engineering, IS and Administration personnel. The batch record review encompasses manufactured batch records, investigation of deviations, exceptions and nonconformance reports.
Minimum 2 years experience
Experience in Batch record review
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® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.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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