Seegene USA, Inc. is a global pioneer in symptom based in vitro molecular diagnostics focusing on advancing science to develop multiplex molecular technologies and to manufacture multiplex in vitro diagnostic devices and reagents. Seegene's core enabling power is the passion for wide spreading of multiplex molecular diagnostics to improve the quality of life and health of people. Using its innovative proprietary technologies, Seegene has been making considerable contributions to giving the most economic and clinic friendly molecular diagnostic solutions for infectious diseases, genetics, pharmacogenetics, and oncology. For more information, please visit www.seegeneUS.com.
QA Associate II will be responsible for assisting in all quality assurance activities as well as maintain quality policies and procedures according to company requirements. Additionally, the QA Associate II will maintain knowledge on all awareness issues and recommend strategies to management.
What we offer:
Amazing team to work with
Seegene pays 100% of Health insurance/Life/STD/LTD premium for the employee, and 70% for dependents. Other voluntary insurance also available.
Generous 401k, no vesting period, no waiting period
Generous PTO, Corporate holidays, Unlimited sick,
Various employee discounts and perks
Job Responsibilities:
Assist in the improvement of SOPs, work instructions, policies, procedures, job aids, and business process communications
Participate in documenting reports for tracking and trending of events
Maintain records and revision control in the SGUS electronic Quality Management System (eQMS)
Participate in evaluation of customer complaints, initiation of CAPA Investigations, tracking and trending of events
Aid in maintaining training and safety documentation for employee records and audits
Perform Verifications, Inspections, and maintaining equipment records and certifications
Learn the use of process mapping techniques, lean, or Six Sigma process improvement methodology to reduce waste
Participate in corrective action investigations, process improvement teams, audits, customer visits and strategy discussions
Contribute to Supply chain audits, client audits, and internal process audits with the Quality Manager
Assist in documenting minutes for audit report write-ups
Participate in corrective action investigations, process improvement teams, audits, customer visits and strategy discussions
Competencies:
Problem Solving. A clear understanding of the compliance requirements is preferred, and the ability to collect objective evidence for investigations can help solve problems, typically in situations where general standardization should exist, but may not be operating effectively
Team Player. Ability to be involved in teams and meetings at every level of the organization Must possess excellent verbal and written communication skills
Organization and prioritization skills with an excellent attention to detail
Able to understand and comply with established company policies and procedures
Passion and alignment with our mission, vision, values & operating principles
Passion for working in a values-based company in alignment with a learning organization
Exhibit a passion for the company's Essence and Corporate Direction
Desire to own decisions and take responsibility for outcomes
Minimum/Required Qualifications:
Bachelor's degree in engineering or science related fields
2 years prior experience in Quality Assurance or Quality related field
Must be familiar with Quality Standards. Experience with Good Manufacturing Practices (GMP), FDA Quality Systems Requirements (21 CFR Part 820), and ISO standards (i.e. ISO 13485)
Demonstrated experience working with contract manufacturers, suppliers, or distributors
Proficiency in Microsoft Office
Experience in quality management systems
Additional/Preferred Qualifications:
Experience with Diagnostic Labs, Life Science, Biopharma or related business
Understanding of GMP regulations
Experience with eQMS (such as Master Control, Greenlight Guru, Veeva, TrackWise, etc.)
Seegene USA, Inc. is an equal opportunity employer. Each position at the company is filled by the best qualified applicant available. The company does not discriminate against employees or applicants on any legally protected basis, including, but not limited to, race, color, religion, gender, gender identity, marital status, sexual orientation, national origin, ancestry, veteran's status, age, or disability which does not interfere with an individual's ability to perform the essential functions of his or her job position with or without reasonable accommodation. The company will provide equal opportunities in hiring, promotions, wages, benefits and other privileges, terms and conditions of employment. It is our policy to encourage promotion from among present employees, subject to the application of the best-qualified employee.