Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Quality Analyst at a prestigious Fortune 500® company working in Irvine, CA.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position (Brooke.Schoen@kellyservices.com) however your resume must be received via the “Submit Resume” button included within.
Pay: $30.60 per hour depending on experience
This position is responsible for performing the Review of Finished Product for Commercial Distribution, Launch/Validation Batches, Pilot Batches and Media Fills. This position ensures that all investigations and/or any special studies are adequately and appropriately documented and reported in the batch records. This position also performs the disposition of Miscellaneous Materials (Primary/Secondary Components, Labeling Components and Chemicals (Excipients/Active Pharmaceutical Ingredients) used in Production Operations.
Essential Duties & Responsibilities Percentage of Time
1. Responsible for the Batch Record review of products for commercial distribution products, validation lots, pilot lots and media fills. Reviews the associated batch record documentation including but not limited to sterilization records, equipment charts, supporting validation reports. Verifies the acceptability of investigation reports, change controls, holds and chemical and microbiological testing. 50 %
2. Works with all facets of the company including technical representatives from Operations, Validation, QA and QC to assure that batch record entries are properly performed following cGDP / cGMP and that all issues are resolved in a timely fashion and that any special studies performed in manufacturing are accurately documented and reported. 10 %
3. Approves and Dispositions components, raw materials and finished products utilizing the LIMS and the ERP systems
4. Provides accurate and technical feedback regarding the review status of batches and works closely with the Planning and Distribution management to track Company performance in regards to Monthly Release Commitments. 10 %
5. Assists management of QA Product Release in the preparation of the APR sub-reporting.
6. Issues, Reviews, evaluates, revises, and/or approves miscellaneous documentation including but not limited to gDRs, gCAPAs, Holds, gCCM’s and SOP’s. 10 %
Education Required: High School Diploma/GED
Experience with 1 to 3 years’ experience in
Pharmaceutical manufacturing operations.
Good computer skills and ability to work with all levels of personnel.
Must be skilled at problem solving analysis and
Education Preferred: 4-year degree in Science or Life Science field.
Experience Required: Minimum 1 year of experience in Pharmaceutical manufacturing operations or related
work experience. Formal training with regards to
Experience Preferred: Minimum 3 years of Pharmaceutical or related work
experience, and requirements as stated above.
• Excellent understanding of cGMP's and their importance in Documentation Control/Product Release. Computer Literacy in standard software as well as some database management
Planning & Organizational
• Exercise judgment in developing practices, techniques and evaluation criteria for obtaining results.
• Must be able to interface with all levels of management, peers and subordinates. Remains calm, self controlled, and poised under all types of job pressure and responsibility.
• Excellent written and verbal skills. Writes and speaks fluently, clearly and concisely. The individual is effective and confident communicating in a variety of settings both inside and outside of the organization.
We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com.
Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.
Kelly Services is an Equal Opportunity Employer
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