Position Summary:

The Quality Assurance Specialist III – Supplier Management will provide advanced-level, hands-on support from a regulated systems perspective in a GxP laboratory services and kitting production environment. This position is also responsible for working closely with laboratories affiliated as Precision Laboratory Network (PLN). While this role is focused on Supplier management, this role may extend to other function within the Quality Assurance team. Extended work hours may be necessary to meet business demands.

Essential functions of the job include but are not limited to:

· Establish and maintain an effective Supplier Management process by:

o Leading supplier qualification

o Scheduling and performing periodic monitoring of qualified suppliers.

o Assisting in scheduling, performing, and reporting supplier audits including for cause audit

o Maintaining the Approved Supplier List in a current state

o Preparing and managing Quality Agreements with suppliers

o Establishing relationships with suppliers to ensure open communication and collaboration

o Managing SCAR in a timely manner

o Sharing supplier notification with appropriate key stakeholders

o Reporting and analyzing data resulting from monthly metrics and reporting tools for all aspects of quality systems, connecting data and forming conclusions regarding the compliance health of PFM, to include presentation of metric performance to management representatives and proposing durable solutions

· Support the backroom during external audits and regulatory inspections, review requested documentation and records, and assist in preparing subject matter experts for audit interviews

· Lead departmental projects aimed operational process understanding efforts (process mapping) as needed

· Act as a change-agent and QA lead during continuous improvement and global harmonization efforts

· Provide guidance to junior level QA specialists

· Client-facing activities as assigned by department head such as leading client visits/audits and representing QA during project kick-off meetings and customer complaints

· Develop in collaboration with key stakeholders contingency plans and risk mitigation strategies for supply disruptions or quality issues.

· Ensure compliance with regulatory requirements and industry standards.

· This role may also support the quality team with other responsibilities such as non-conforming events, complaints, and change control.

· This role may also be involved in supporting Quality Agreement with PFM’s clients.

· Assist in the QA review and acceptance of customer specifications to conform to contractual requirements

· Provide support to other departments regarding requests, release status, regulatory requirements and other tasks as requested

· Work with functional groups to develop correct documentation required to document evidence for the manufacturing/processing, testing and release of products and services

· May provide support for the inspection and release of incoming raw material, critical components, packaging and labeling in accordance with individual specifications and standard operating procedures

Miscellaneous:

· Participate in regulatory, notified body, and customer audits as needed

· Provide back-up coverage for other Quality Specialists

· Carry out other duties/projects as assigned

Qualifications:

Minimum Required:

· Bachelor’s Degree or equivalent combination of education and experience

· 4 years of related experience in a life science, regulated environment

Other Required:

· Experience working in a Quality Department/Life Sciences-Regulated environment including supplier management

· Experience with ISO 9001, ISO 15189, ICH E6(R2)

· Knowledge of root cause analysis tools and application, identifying durable corrective/preventative actions, and participating in process improvements

· Ability to meet deadlines and perform administrative functions

· Microsoft Office suite proficiency including Office Word, Excel, PowerPoint

· Ability to organize tasks, work independently and adapt to changing priorities

· Ability to function independently within a minimally supervised environment with exceptional attention to detail required

· Demonstrated highly developed communication skills including well-developed writing skills and verbal and interpersonal skills

· Must be able to read, write, speak, fluently and comprehend the English language