The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
A Bio - Pharmaceutical Company is seeking a QA Operations Specialist in Frederick, MD..
Role is 100% on site *Successful candidate must meet the our requirements for Covid vaccination PRIOR to starting We are seeking a highly motivated individual to join us as QA Operations Specialist II at our commercial manufacturing site in Frederick, MD. In this position, you will provide Quality Assurance oversight of Commercial Manufacturing, Materials Management, and Quality Control areas. Must be proficient in Quality Systems, particularly associated with Operations and Management / CAPA. This position will work 4 – 10 hour days, Wednesday to Saturday, 0700 – 1730.
• Work with the Commercial Manufacturing, Quality Control, Materials Management and Facilities/Engineering departments as a Quality Assurance representative.
• Coordinate and facilitate Quality Assurance related production and production related activities, including: o Assessment and closure of discrepancies, deviations and change controls requests. o On-the-floor support Quality support to manufacturing and QC staff. o Assessment and closure of laboratory investigations. o Timely assessment and closure of batch and material hold events. o Review of batch manufacturing and testing documentation for timely delivery of final product.
• Ensure that tests are performed, and products are manufactured in compliance with Kite specifications, regulatory and GMP guidelines.
• Support development of SOPs and review/approve SOPs to ensure quality objectives are met
• Review and approve test methods, manufacturing/quality control qualification/validation protocols and reports.
• Compile and verify all batch related documents into a final product lot disposition package.
• Perform/review and approve quality investigations of manufacturing deviations, GMP and quality system issues, non-conforming materials, and CAPA. o Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues. o Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities. o Provide periodic updates to management for deviations, GMP and system issues, non-conforming materials and products, and CAPA.
• Perform other duties as required.
Skills & Requirements
• Bachelor’s degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 3-5 years of experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
• Must be proficient in Quality Systems, particularly associated with Operations and Exception Management/CAPA.
• Strong knowledge of GMP, SOPs and quality systems.
• Ability to effectively negotiate and build collaboration amongst individuals.
• Strong interpersonal, verbal and written communication skills.
• Experience with laboratory investigations, deviations, and CAPA.
• Experience with change control practices and strategies.
• General knowledge of aseptic manufacturing processes.
• Proficient in MS Word, Excel, Power Point and other applications.
• Ability to communicate and work independently with scientific/technical personnel.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities.
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.
Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.
• Life Insurance ($20,000 benefit)
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Hays is an Equal Opportunity Employer including disability/veteran.
In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570
Drug testing may be required; please contact a recruiter for more information. #1142810
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