- 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.
- 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.
-
Quality Assurance Specialist
3 weeks ago
PBS Biotech Camarillo, United States**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 ...
-
Quality Assurance Specialist
3 weeks ago
Child Development Resources of Ventura County, Inc Oxnard, United StatesUnder the supervision of the quality assurance coordinator, the quality assurance specialist shall be responsible to: · 1. Maintain knowledge of and compliance with community care licensing regulations, funding terms and conditions, Title 5 and 22 Regulations, welfare and institu ...
-
Quality Assurance Specialist
2 weeks ago
PBS Biotech Camarillo, United StatesJOB 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 · GENE ...
-
Quality Assurance Specialist
1 week ago
SaniSure Inc Camarillo, United StatesJob Description Job Description ABOUT SANISURESaniSure is a multinational manufacturer of single-use bioprocessing solutions (SUT) used in the production of biological drugs, including monoclonal antibodies, cell therapies, gene therapies, and vaccines. With operations in the U.S ...
-
Quality Assurance Specialist
2 weeks ago
SaniSure LLC Camarillo, United StatesJob Description · Job DescriptionABOUT SANISURE · SaniSure is a multinational manufacturer of single-use bioprocessing solutions (SUT) used in the production of biological drugs, including monoclonal antibodies, cell therapies, gene therapies, and vaccines. With operations in th ...
-
Quality Assurance Specialist
2 weeks ago
PBS Biotech Camarillo, United StatesJOB 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 · GEN ...
-
Quality Assurance Specialist
2 weeks ago
PBS Biotech Camarillo, United StatesJOB 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 · GENE ...
-
Quality Assurance Specialist
1 week ago
PBS Biotech Camarillo, United StatesJOB 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 - $105kGENERAL PURPOSE This role supports the implementa ...
-
Quality Assurance Specialist
4 weeks ago
PBS Biotech Camarillo, United States 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 PURPO ...
-
Quality Assurance Specialist
2 weeks ago
SaniSure Inc Camarillo, United StatesJob Description · Job Description · ABOUT SANISURE · SaniSure is a multinational manufacturer of single-use bioprocessing solutions (SUT) used in the production of biological drugs, including monoclonal antibodies, cell therapies, gene therapies, and vaccines. With operations i ...
-
Senior Quality Assurance Specialist
3 weeks ago
PBS Biotech Camarillo, United StatesCompany: PBS Biotech, Inc. Department: Quality Position/Title: Sr. QA Specialist – Computerized Systems Location: Camarillo, CA Reporting To: Dir. of Quality Management FLSA Status: Exempt Pay Range: $104,300 – $116,450 - $127,850 GENERAL PURPOSE In accordance with the QMS and Qu ...
-
Quality Assurance Specialist
3 weeks ago
Aequor Thousand Oaks, United StatesMCS Senior Associate Quality Assurance (DAY & SWING SHIFT Onsite Job) · Location: Thousand Oaks, CA · Terms: Contract W2 · Duration : 06 Months Contract (Can Be Extended For Long) · FULLY ONSITE AT Thousand Oaks, CA · DAY & SWING SHIFT · Job Description · Must be flexible as it i ...
-
Quality Assurance Compliance Specialist
1 week ago
Jobot Oxnard, CA, United StatesGlobal Ingredients Company / Amazing Career Opportunities This Jobot Job is hosted by: Ray Bahl · Are you a fit? Easy Apply now by clicking the "Apply" button · and sending us your resume. · Salary: $85,000 - $110,000 per year A bit about us: We are a global sustainable food ...
-
Quality Assurance Compliance Specialist
6 days ago
Jobot Oxnard, United StatesGlobal Ingredients Company / Amazing Career Opportunities · Is this the next step in your career Find out if you are the right candidate by reading through the complete overview below. · This Jobot Job is hosted by: Ray Bahl · Are you a fit? Easy Apply now by clicking the "App ...
-
Quality Assurance Compliance Specialist
1 week ago
Jobot Oxnard, United StatesJob Description · Job DescriptionGlobal Ingredients Company / Amazing Career Opportunities · This Jobot Job is hosted by: Ray Bahl · Are you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume. · Salary: $85,000 - $110,000 per year · A bit about us: ...
-
Product Assurance Specialist
6 days ago
ITT, Inc. Valencia, California, United States PermanentPosition Summary: · About the Company: · ITT, headquartered in Stamford, CT, operates competitively in more than 35 countries with sales in approximately 125 countries and partners with customers to deliver enduring solutions to the key industries that underpin our modern way of ...
-
quality assurance specialist
3 weeks ago
Department Of The Navy Point Mugu, United States Full timeSummary · This is a public notice flyer to notify interested applicants of anticipated vacancies through the Certain Competitive Service / Modified Direct Hire Authority. Applications will not be accepted through this flyer. Interested applicants must follow the directions in the ...
-
quality assurance specialist
1 week ago
Air National Guard Units Port Hueneme, United StatesSummary This QUALITY ASSURANCE SPECIALIST position is located in an Air National Guard Aviation Wing, Maintenance Group and is part of the CA 146 AW. Responsibilities THIS IS A T32 EXCEPTED SERVICE, PERMANENT POSITION The primary purpose of the QUALITY ASSURANCE SPECIALIST, GS , ...
-
Incident Compliance Specialist
2 weeks ago
R&D Transportation Services Inc. Camarillo, United States**Job Title**:Incident Compliance Specialist · **Department**: Customer Service · **Location**:Camarillo, CA · **Reports To**:Customer Service Supervisor · **FLSA Status**:Full Time, Non-exempt · **Wage Scale**:$22.00-$23.00 · **THE COMPANY** · Since 1991, R&D Transportation Serv ...
-
Youth Shelter Team Lead
3 weeks ago
Interface Children & Family Services Camarillo, United States**SUMMARY**: · The Youth Crisis & Homeless Services helps prevent and address youth homelessness by providing a continuum of supportive services with access to emergency and permanent housing. This position is part of the Basic Center Program/Youth Shelter Team and reports to the ...
Quality Assurance Specialist - Camarillo, United States - PBS Biotech
Description
Job Description
Job DescriptionJOB DESCRIPTIONCompany: PBS Biotech, IncDepartment:QualityPosition/Title:Quality Assurance SpecialistLocation:Camarillo, CAReporting To:Senior Manager, Quality Assurance FLSA Status:ExemptSalary Range$86k - $95k - $105kGENERAL PURPOSEThis 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.
ResponsibilitiesEssential 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
Knowledge/ Experience
Powered by JazzHR
mbp1ciF7Dy