Senior Quality Assurance Specialist - Quality Management Systems
Location
Camarillo, CA | United States
Job description
Company:
PBS Biotech, Inc.
Department: Quality
Position/Title: Sr. Quality Assurance Specialist – Quality Management Systems (QMS)
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 Quality Policy, the Sr. QA Specialist – QMS supports the implementation and continuous improvement of PBS’s Quality Management System (QMS), and supports Quality related programs such as Management Review, Document Management, and Training. This includes supporting internal audits, customer audits, and regulatory affairs including regulatory related requests at PBS Biotech, Inc. (PBS).
Additionally, this role oversees assigned quality related programs and processes. Supports GxP compliance and regulatory related requirements, and customer requests. Interfaces with QMS and eQMS users to define, implement, and improve assigned QMS processes and procedures.
Knowledge and experience with Quality Management System (QMS) and electronic Quality Management System (eQMS) is required. Additional leadership and project assignments will be assigned based on the needs of the business.
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.
Primary Responsibilities
- Support the company’s efforts for cGMP qualification and ISO 9001:2015 certification.
- Perform role of Process Owner for assigned processes including owning procedures, procedure creation/updates, training, and data trending/reporting.
- Supports the deployment of QMS processes and promotes on-going education of the QMS and regulatory requirements including Quality orientation training for new GMP employees as part of the on-boarding process and GMP refresher training.
- Facilitate quality management systems operational mechanisms which may include Change Review Board, Management Review, data entry, etc.
- 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 and may execute suggested remediation activities.
- Responsible for continuous improvements of assigned processes. Identify opportunities for and lead or participate in continuous improvement of the QMS program, which may include seeking feedback from stakeholders.
- Support development of procedures, work instructions, etc., for the QMS.
- Assist in the design, implementation, and deployment of electronic quality management systems.
- Provide assistance to internal and external customers in support of departmental functions related to quality management systems for various quality processes.
- 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.
- This role is considered a QA function and may provide QA approvals where assigned.
- Support QMS initiatives as assigned.
- Will be assigned additional tasks and projects as needed to meet business objectives.
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. The position requires experience with deployment and maintenance of computerized systems in a GMP environment. This role requires effective leadership, collaboration, technical writing, and verbal communication skills.
Knowledge/ Experience
- BA/BS w/ 8+ years of relevant experience with Pharmaceutical Quality systems or 15+ years of experience.
- Experience in implementing and/or supporting one or more of the following Quality applications: Electronic Quality Management Systems, Electronic Document Management Systems, Learning Management System.
- Excellent verbal and written communication skills including excellent technical writing skills.
- Advanced skills with MS Office applications Word, Excel, as well as Adobe Acrobat.
Skills/ Abilities Pertinent to This Position
- Experience with a quality management system in drug/biotech/pharma (21CFR210/211), medical devices (21 CFR 820, ISO 13485/14971) or medical products (ISO 9001, ISO 13485).
- Experience with eQMS (EDMS, LMS, etc.). Experience with Veeva eQMS, CMMS (BMRAM), and ERP (GSS) is a strong plus.
- Excellent technical writing and excellent verbal communication skills.
PHYSICAL DEMANDS
In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job. Must be able to see, hear, speak and write clearly in order to communicate with employees and/or vendors.
WORK ENVIRONMENT
In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment. This role is primarily office work with some tasks or evaluation performed in a production or lab-like environment. May be required to perform some tasks in the following environments: Clean room; Near moving mechanical parts, fumes, machine lubricants, airborne particles, vibration, and risk of electrical shock, high noise while in the manufacturing plant. Personal protective equipment (vision and hearing) used in plant.
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