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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.
Job 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
Bachelor’s degree in Science preferably in Biology, Chemistry, Biotechnology or Engineering
2 years experience in audits
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.
You should know:
Your safety matters! Visit the COVID-19 Resource Center for the latest information, policies, and frequently asked questions.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 worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits 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, were obsessed with where it can take you. To us, its about more than simply accepting your next job opportunity. Its the fuel that powers every next step of your life. Its 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 lifejust 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 Kellys Human Resource Knowledge Center.Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
