QA Compliance Specialist
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![]() United States, Kansas, Lenexa | |||||||||
![]() 8906 Rosehill Rd (Show on map) | |||||||||
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QA Compliance Specialist The success of a company depends on the passionate people we partner with. Together, let's share our talents. Your Location: Lenexa, KS
This position is responsible for ensuring compliance with internal SOPs, global policies, and applicable animal health regulations, within the Quality organization of the Ceva Animal Health Lenexa campus.
* Partner with QA Management to develop training matrices for each position within the Quality organization. * Monitor SOP issuance and provide notification of training to be completed to relevant QA personnel, based on established training matrices. * Routinely review employee compliance with training matrices, owning the follow-up as needed to ensure timely completion, and escalate outstanding training to QA management, as applicable. * Monitor seed inventory status and manage transfer of seed between campuses as needed to meet Production demand. * Schedule and manage calibration and maintenance of seed and cell freezers, serving as the primary point of contact for these dedicated storage units. * Manage seed coordinator weekend schedule, ensuring coverage to meet Production needs and participating in the weekend rotation, as needed. * Support implementation of the CQMS document module. * Provide support to other QA areas, as needed (eg. information gathering for product quality reviews and assistance with routine supplier oversight activities).
* Shape solutions out of complexity - Is open and curious of other's perspectives * Client focus - Has in mind client's satisfaction * Collaborate with empathy - Has a positive attitude towards collaboration * Engage and develop - Clarifies short-term directions * Drive ambition and accountability - Proactively manages own and others work * Influence others - Communicates effectively
* Proven knowledge of good manufacturing/documentation practices and quality systems principles * Strong analytical and problem-solving skills * Proficient with Microsoft Office; intermediate skills in the creation and manipulation of database / documents / spreadsheets to support business related reports * Strong independent thinking, organizational and time management skills * Excellent written and verbal communication skills * Strong attention to detail and ability to consistently perform and deliver lasting results within ambiguous situations * Energetic and self-motivated; ability to work with minimal supervision
Education: High school diploma required; Bachelor's degree in science-related field or equivalent preferred. Relevant experience may be considered in lieu of a 4-year degree. Work Experience: 2+ years' experience in a regulated biotech or pharmaceutical environment. Other: Quality Management Systems (QMS) experience required (preferably in a USDA regulated environment).
* Ability to read, write legibly and communicate in English * Ability to move between different buildings and Lenexa locations (by vehicle), if needed.
* This is an onsite position, Monday through Friday, with some weekend work possible. * Occasional work in and around liquid nitrogen storage tanks (-196C).
Local travel between Lenexa campuses only. This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business. *VEVRAA Federal Contractor 669B #USCEVA Your Education: High school diploma required; Bachelor's degree in Work Experience: 2+ years' experience in a regulated biotech or Other: Quality Management Systems (QMS) |