Quality Specialist II
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Job Location:
San Jose, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Under minimal supervision the Quality Assurance Specialist II will ensure systems and processes are in a state of compliance with regard to internal regulatory and industry standards. He/she will promote a culture of quality for the Company. Candidates in this position will routinely report on the performance of the Quality System to senior leadership. Additionally candidates will identify CAPAs NCMRs Change Controls Process Improvements and execute Root Cause Analysis. Candidates will participate in both internal (annual for cause etc.) and external (client regulatory agencies accreditation bodies etc.) audits. Candidates will maintain the Controlled Document System and all associated tasks necessary to keep this system functional current and compliant.
Essential Duties/Responsibilities:
- Participate in all aspects of Quality Assurance to ensure sterilization activities are performed in compliance with both internal procedures and external cGXP/ISO requirements.
- Participate in the internal auditing program to ensure the established techniques are followed and understood.
- Participate in the planning preparation and hosting of customer regulatory and accreditation audits; respond to audit reports and implement resolution of audit findings; complete Supplier assessment evaluations.
- Maintain and control site-specific procedures including Standard Operating Procedures Protocols Forms NCMRs CAPAs Deviations Complaints/Inquiries Change Orders quality data sheets/records calibration records training records and logs.
- Manage and control the Document System in compliance with the FDA regulations ISO 13485:2016 guidelines and company policies.
- Review Work Order forms.
- Audit various reports prior to issuance (e.g. validation reports audit reports etc.). Serve as site contact for quality inquiries on reports and related documentation.
- Create revise review and approve newly written documents and document revisions.
- Work with Operations Management to maintain the training program and ensure that operations personnel have completed all necessary training requirements.
- Train site personnel in GXP/ISO procedures practices and guidelines.
- Maintain Customer validation report logs and requalification due dates
- Initiate and process DCOs NCMRs and CAPAs and participate in related investigations and document findings with data
- Assist management in preparing for the Management Review process.
- Assist management in ensuring all licenses remain current (e.g. ISO FDA City etc.)
- Collect track and analyze quality metrics (OOS NCMRs CAPAs complaints etc.) and train
laboratory personnel as needed to help reduce quality events. - Monitor laboratory compliance with respect to lab cleanliness training records and other ISO/GMP-related items as needed to help minimize laboratory errors and audit findings.
- Assist senior leadership in maintaining the list of approved suppliers and subcontractors.
- Exist as a backup for other Quality Assurance personnel.
- Other duties as assigned by departmental management.
Qualifications :
Education:
- Bachelors degree in chemistry biological science or other related life science field.
Experience:
- 1-3 years of laboratory quality assurance experience.
- Must have experience working in a GMP facility.
- ISO 13485:2016 accredited lab experience preferred.
- Moderate understanding of sterilization processes and procedures
Capabilities:
- Must be a detail-oriented self-initiating individual with strong interpersonal written and oral communication skills.
- Strong organizational skills and ability to multitask in a dynamic fast-paced
environment. - Displays sound judgment and ambition; is quality focused; displays good communication skills; good implementation and follow-up skills.
- Hands-on experience with CAPA NCMR change control and validation documentation (IQ/OQ/PQ).
- Strong problem-solving skills including root cause analysis using formal RCA
tools such as Ishikawa and 5Ys.
Additional Information :
Position is full-time Monday - Friday 7:30am - 4:00pm. Candidates currently living within a commutable distance of San Jose CA are encouraged to apply.
The pay rate of this role is $28.00/hr
- Excellent full time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more
