What are the responsibilities and job description for the QA Specialist position at Kaneka Americas Holding, Inc.?
DescriptionQualifications
Education
Experience
EQUAL OPPORTUNITY EMPLOYER
Kaneka Americas Holding, Inc. is an equal opportunity employer committed to cultural diversity in the workforce. Applicants will receive fair and impartial consideration without regard to race, color, religion, sex, national origin, protected veteran or disability status, genetic information, age, or any other factor protected by law.
- Serve as the direct contact and QA support for the Probiotics unit:
- Perform contract manufacturing audits; domestic and international.
- Complete batch review, release and issue COA's
- Lead quality investigations to resolve product quality issues and completed CAPA
- Create routine reports to communicate status, needs and KPI's
- Create, revise, review and approve Quality Assurance standard operating procedures (SOPs).
- Facilitate/Conduct thorough investigations into quality issues, deviations, complaints, and non-conformances in accordance with ISO9001 and GMP guidelines.
- Utilize problem-solving techniques such as root cause analysis (RCA), failure mode and effects analysis (FMEA), and other quality tools to identify the underlying causes of issues.
- Collaborate closely with cross-functional teams including manufacturing, R&D, regulatory affairs, and quality control to resolve issues promptly.
- Aid peers in developing and implementing effective CAPAs to address identified root causes and prevent recurrence of quality issues.
- Ensure all investigations and CAPAs are documented accurately and in compliance with company policies and regulatory requirements.
- Monitor the effectiveness of implemented CAPAs through follow-up activities and trend analysis.
- Provide support during regulatory inspections and audits related to quality investigations.
- Provide recommendations to improve/reduce frequency of quality events.
- Review Production Batch Records for batch release.
- Support QA inspection and verification functions such as shipping, cleaning and sanitation, etc.
- Provide coaching for QMS software navigation and form entry.
- Maintain trend analysis and create presentations of key quality indicators such as complaints, non-conformance, deviations, action items, OOS
- Perform Raw Material Supplier, Contract Manufacturer, and Contract Laboratory Reviews /Audits
- Support and participate on HACCP/ Food Safety and Food Defense teams.
- Support cleaning and sanitation verification activities
- Must demonstrate the following emotional intelligence skills:
- Emotional Empathy
- Positive Attitude
- Excellent Communication Skills
- Flexibility / Adaptability
- Interpersonal Skills
Education
Bachelors of Chemistry (required)
Experience
Experience with electronic Quality Management Systems (eQMS) and document control systems. (preferred)
Manufacturing environment (required)
3 - 5 years: QMS and Regulatory environment (required)
Manufacturing environment (required)
3 - 5 years: QMS and Regulatory environment (required)
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
EQUAL OPPORTUNITY EMPLOYER
Kaneka Americas Holding, Inc. is an equal opportunity employer committed to cultural diversity in the workforce. Applicants will receive fair and impartial consideration without regard to race, color, religion, sex, national origin, protected veteran or disability status, genetic information, age, or any other factor protected by law.
