Overview
Quality Assurance (QA) Specialist II Jobs in Barceloneta, PR at Artech LLC
Location: Lenexa, KS
Job Summary and Purpose:
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.
Responsibilities and Key Duties:
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).
Core Competencies and Attitudinal Characteristics:
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
Technical / Functional Competencies:
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
Qualifications:
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).
Physical Requirements:
Ability to read, write legibly and communicate in English
Ability to move between different buildings and Lenexa locations (by vehicle), if needed.
Working Conditions:
This is an onsite position, Monday through Friday, with some weekend work possible.
Occasional work in and around liquid nitrogen storage tanks (-196°C).
Travel Required:
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
**Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.
669B
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Your profile :
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).
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Title: Quality Assurance (QA) Specialist II
Company: Artech LLC
Location: Barceloneta, PR
