QA Specialist - The Fountain Group
Woodland, CA
About the Job
The Fountain Group is currently seeking a QA (Quality Assurance) Specialist for a prominent client of ours. This position is located in Woodland, CA. Details for the position are as follows:
Job Description:
**ONSITE: Monday-Friday, standard business hours (1st shift)**
Job Description:
**ONSITE: Monday-Friday, standard business hours (1st shift)**
- Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for site.
- Responsible for new product setup, quality project management, and regulatory compliance of serum products.
- Ensure compliance to in-house and/or external specifications and standards such as cGMPs, 21 CFR 820, ISO 13485, and Quality System Procedures.
- Day to Day Responsibilities:
- Ensure compliance to new and changing regulations affecting products and processes including, but not limited to, QSR's, global import/export regulations, etc.
- New product setup and management of related projects.
- Assist with Supplier audits, as needed.
- Maintenance of BSE Serum Certificates of Suitability filing with EDQM.
- Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits.
- Serve as a resource for customer's regulatory and technical inquiries.
- Ongoing maintenance of ISO 13485 based quality system.
- Implement and handle CAPA (Corrective and Preventive Actions) and problem resolution.
- Coordinates and leads Quality Documentation, Nonconformance Reports, Inspection Activities, and Product Disposition.
- Coordinates the review and revision of procedures, specifications, and forms to maintain and improve the QMS.
- Quality Help Desk and customer complaint point of contact and problem resolution including Questionnaires, Certificates and Customer Surveys, etc.
- Perform Internal Audits in support of internal requirements, 21 CFR 820 and ISO 13485 compliance.
- Assists in representing in customer quality audits, supplier quality audits and regulatory inspections
- Performs investigations and analysis activities to support resolution of quality issues.
- Collaborates with organizational teams to support quality system implementation.
- Creation of new product master files satisfying customer and quality system requirements.
- Ensures quality standards by following company & departmental policies & procedures including, but not limited to:
- Product performance & quality verification
- Identifying, recording, and investigating problems related to product, process & quality systems
- Evaluating processes for improvements and standardization
- Initiating action to prevent non-conformance in products, process, and quality systems.
- Training on quality systems and applicable regulations as identified by supervisor and required by position.
- Tracking/trending aspects of the QMS.
- Other job duties as required.
- BS (biology/chemistry preferred)
- 3+ years of quality experience (med device or biotech/pharma preferred)
- Experience in new product setup, quality project management, and regulatory compliance required
- Required Skills: root cause analysis / root cause investigations | CAPAs | non-conformance | investigation/deviations | track/ identify trends in quality issues | performing internal/external audits | nonconforming materials and products
- Preferred Skills: Customer Complaints | Experience with Serum Products
- Experience with QMS (Quality Management Systems)
- Ability to monitor the QMS such as: Change Control, CAPA, Complaints…
- RA experience (regulatory affairs / regulatory compliance)
- cGMPs + ISO required
- ISO 13485 + 21CFR 820 preferred
- Some Project Management (PM) experience
- Six Sigma
- Preferred Certifications: Six Sigma Certification | ASQ Certification
- Preferred Skills: Continuous Improvement | Lean
Source : The Fountain Group
