Sr. Quality Assurance Specialist - Training And Document Control

This role is responsible for the Training program to support the Quality Management Systems (QMS). This role will be responsible for the implementation, deployment, and maintenance of the Training program as well as providing quality oversight of PBS’s training program.

This role will be responsible for supporting the timely, accurate, and efficient preparation and management of documents in Document Control for PBS’s QMS. This includes supporting the Periodic Review program, and controlling the numbering, sorting, filing, storing and retrieval of both electronic and hard copy documents.

Responsibilities

Support the QMS implementation, ensure suitability, and continuously improve the structure and processes. Oversee assigned quality-related programs and processes such as Training and document control administration. Support GXP compliance and regulatory-related requirements, audits, and customer requests. Interface with QMS users to define, implement, and improve assigned QMS processes and procedures.

Primary Responsibilities

• Support internal and external audit and inspection activities through retrieval and provision of requested quality management systems documents and data in a timely manner. Service as a subject matter expert.
• Review and approve training materials, procedures, work instructions, etc., for adherence to applicable regulations regarding training.
• Help manage the storage of physical and electronic documents, including scanning records, and maintaining incoming documentation from contractors, suppliers, and customers.
• Responsible for creating training materials and training staff on the Training program, leading training sessions, and ensuring proper execution of the Training program; including Quality orientation training for new GMP employees as part of the on-boarding process and annual GMP refresher training.
• Help manage document control processes and systems for compliance with internal procedures and policies as well as regulatory requirements.
• Provide assistance to internal and external customers in support of departmental functions related to Training and Quality Management Systems.
• Help oversee the creation and management of document format and content templates.
• Assignment may vary based on business needs.
• Support the deployment, maintenance, and continuous improvement of electronic Learning Management Systems (LMS) and Electronic Document Management System (EDMS).
• 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.
• Support the development of document control procedures including the creation, routing review, approval, distribution, and archiving of new, revised, and obsoleted controlled documents.
• Support the company’s efforts for CGMP qualification and ISO Certification.
• Help manage the Periodic Review program to ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedures.
• Support the Document Control by performing tasks as assigned:
• Identify opportunities for and participate in continuous improvement of the QMS program, which may include seeking feedback from stakeholders.
• Conduct tracking & reporting for the Training program, 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.
• As the Training process owner, be responsible for the implementation, deployment, maintenance, and continuous improvement of the Training program. Promotes on-going education of GMP Training, QMS, and regulatory requirements.
• Help establish and maintain records management system including secure storage, retrieval, retention, and destruction.
• Work collaboratively with process owners and management to facilitate the development of training activities specific to their individual department needs, to help drive staff skill improvement. Facilitate and support the creation of company training materials.
• Maintain a state of inspection readiness and participate in inspection preparation activities.

Minimum Qualifications

5-10 years in a Quality role and/or 5 years of combined experience in a product-related role such as manufacturing operations, product testing, validation, or investigations.

5-10 years of experience in a role for medical products in a regulated environment or equivalent education. e.g., Bachelor's Degree.

5-10 years of experience within a QMS that requires a high degree of quality control, ideally GMP quality system, medical device (QSR/ISO13485), aerospace (AS 9100), ISO 9001, or other similar systems.

5-10 of experience in a role for medical products in a regulated environment. e.g., medical devices, single-use medical or biopharma products, or similar field.

· Experience supporting the deployment and maintenance of Training QMS and eQMS in a GMP environment, is a plus.