Quality Assurance Associate II
3 days ago
About Seegene USA, Inc.
Seegene USA, Inc. is a global leader in the development and manufacturing of molecular diagnostics solutions. Our mission is to improve the quality of life and health of people by advancing science and technology.
Job Summary
We are seeking a highly motivated and detail-oriented Quality Assurance Associate II to join our team. The successful candidate will be responsible for assisting in all quality assurance activities, maintaining quality policies and procedures, and recommending strategies to management.
Key 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
Requirements
- 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
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.)
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
Equal Opportunity Employer
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.
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