Quality Assurance Specialist

4 weeks ago

Camarillo, California, United States PBS Biotech Full time


JOB DESCRIPTION


Company:
PBS Biotech, Inc
Department:
Quality
Position/Title:
Quality Assurance Specialist
Location:
Camarillo, CA
Reporting To:
Senior Manager, Quality Assurance
FLSA Status:
Exempt
Salary Range
$86k - $95k - $105k

GENERAL PURPOSE

This role supports the implementation and continuous improvement of PBS's Quality Management System (QMS), and is responsible for management of programs such as supplier qualification, supplier audits, and supplier quality performance management. This role supports internal audits, customer audits, and regulatory affairs including regulatory related requests.

Responsibilities

Essential functions of the job are listed below. Other responsibilities may also be assigned. Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.

Support the QMS implementation, ensure suitability, and continuously improve the structure and processes. Manage and oversees all aspects of the Supplier Qualification process. Support GxP compliance and regulatory related requirements, external and internal audits, and customer and suppliers' requests. Interface with QMS users to define, implement, and improve assigned QMS processes and procedures.
Primary Responsibilities

  • Support the company's efforts for CGMP qualification and ISO Certification.
  • Manage all aspects of the Supplier Qualification process including generation of metrics and risk management documents.
  • Plan Supplier Quality surveillance activities.
  • Manage supplier qualification activities for low risk (low criticality) to high risk (high criticality) suppliers.
  • Partners with Supply Chain for management and follow up of Supplier Corrective Actions Reports (SCARs) and implements identified improvements and actions if needed.
  • Initiate, review, and approves SCARs.
  • Coordinates completion of Quality Agreements with suppliers.
  • Escalate suppliers/quality issues to stakeholders.
  • Manage, perform, and support supplier quality system audits and assess supplier capability to meet product requirement specifications.
  • Manage Supplier Change Notifications.
  • Performing actions associated with Change Management and Corrective/Preventive Acton's (CAPA), including ownership of these records.
  • Facilitates Root Cause Corrective Action activities with Suppliers as a result of Audit, Compliance, or Product deficiencies.
  • Member of the Supplier Review Board (SRB) team in providing input and data related to deployment of SQM strategy and monitoring of supplier quality continuous improvement.
  • Responsible for continuous improvement of assigned processes.
  • Performs various administrative activities related to supplier quality information in the PBS Enterprise Resource Planning (ERP) system.
  • Support Nonconformances and Customer Complaints where supplier related deficiencies are involved.
  • Support procedure creation/updates, training, and data trending/reporting for Supplier Quality Management.
  • Supports the deployment of QMS processes and promotes on-going education of the QMS and regulatory requirements including Supplier Quality training for involved departments such as Engineering and Supply Chain.
  • Conduct tracking & reporting for the quality programs, including development and monitoring metrics that support key performance indicators (KPIs) for the organization. Provides reports to management, as required. Provides and may execute suggested remediation activities.
  • Identify opportunities for and participate in continuous improvement of the QMS program, which may include seeking feedback from stakeholders.
  • Maintain a state of inspection readiness and participate in inspection preparation activities.
  • Support internal and external audits and inspection activities through retrieval and provision of requested Quality Management Systems records and data in a timely manner. Serve as Subject Matter Expert.
  • Assist in the design and implementation of electronic quality management systems in regard to Supplier Quality Management.
  • This role is considered a QA function and may provide QA approvals where assigned.
  • Assignment may vary based on business needs.

Minimum Qualifications

The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position. Please note that the minimum qualifications may vary based upon the department size and/or geographic location.

Knowledge/ Experience

  • 3+ years of experience within a QMS that requires a high degree of supplier management, quality control, ideally GMP quality system, medical device (QSR/ISO13485), aerospace (AS 9100), ISO 9001, or other similar systems.
  • 3+ of experience in a role for medical products in a regulated environment. e.g., medical device, single use medical or biopharma products, or similar field.
  • Bachelor's Degree – Engineering, Supply Chain Management, Biotechnology, Logistics or related field of study.

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