Job Description

Job Description

Our client (a renowned biopharma CDMO) is seeking to hire a talented Sr. Specialist – Capa Deviations Investigations to join their Quality Assurance group.
\nThis is an individual contributor role primarily responsible for conducting technical quality compliance related activities in accordance with GxP regulations and internal SOP. This SME ensures deviations are thoroughly investigated, root cause is determined, and appropriate corrective actions are identified and implemented based on associated risk to process, compliance or SISPQ. Additionally, the individual is responsible for the oversight and communication of critical metrics regarding deviations and CAPAs. The individual also provides QA review and oversight of Trend Review Reports to identify interrelationships between process inputs and critical process parameters and to identify process shifts. Supports and/or prepares APRs for commercially approved processes to ensure compliance to cGMPs, standard operating procedures, and FDA requirements.
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• TITLE : Sr. Specialist – Capa Deviations Investigations\n\t
• LOCATION: Columbus, Ohio ( onsite )\n\t
• SALARY : $95-105,000 ( commensurate with experience ) \n

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\n Essential Functions: \n\n

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• Oversee and support the prompt evaluation, investigation, closure, and follow-up of unplanned events as well as identify opportunities for continuous improvements.\n\t
• Works with SMEs to ensure thorough root cause analyses, assess impact to SISPQ, and ensures root cause is addressed through appropriate Corrective/Preventive Actions.\n\t
• Works to establish appropriate ownership and timelines for CAPAs about the risk related to the event or issue.\n\t
• Assesses final supporting documentation to complete/close CAPAs as adequate. Conducts CAPA effectiveness checks for high risk events.\n\t
• Communicates critical metrics regarding deviations and CAPAs and chairs the Investigation Review Board meeting. \n\t
• Provides oversight and input to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.\n\t
• Responsible for the preparation of Annual Product Review reports.\n\t
• Acts as the SME and trainer for TrackWise Investigation/CAPA module.\n

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\n Knowledge, Skills and Abilities required: \n\n

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• Minimum of 8 years’ experience GMP/Biopharmaceutical/Biotech Industry, 3-5 years specific QA on experience in a pharmaceutical environment, cell and gene therapy experience preferred\n\t
• Bachelor’s Degree in a technical or scientific discipline or equivalent\n\t
• Operational knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211\n\t
• Demonstrated Project Management abilities to lead and manage several projects, meeting deadlines and use critical thinking skills to problem solve effectively.\n\t
• Excellent verbal and written communication skills to all levels of the organization. Technical writing required.\n\t
• Experience with the authoring and execution of Quality documentation including SOPs, CAPAs, Investigations.\n\t
• Experience with FDA, EMA inspection interaction.\n\t
• Strong experience working in cross-functional team. Ability to influence, negotiate, manage conflict and collaborate.\n\t
• Must demonstrate a “can-do” attitude. \n\t
• Proficient in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint). Knowledge of application software such as Trackwise, SAP, preferred.\n

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\n Minimum Physical Requirements \n\n

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• There are very minimal physical requirements. \n\t
• One needs to be able to lift 20-30 pounds occasionally, bend, reach or balance (0-33% of the time).\n\t
• Requires ability to aseptically gown or wear other PPE required as needed.\n\t
• Must be able to stand for extended periods.\n

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\n\t\t\t\tAs 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.

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Job Tags

Holiday work, Temporary work, Work experience placement, Local area, Shift work,

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