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Sr. Quality and Compliance Specialist

Company: PerkinElmer
Location: Thousand Oaks
Posted on: October 16, 2020

Job Description:

Job Description

Job Title: Quality and Compliance Specialist Purpose Execute customer and PKI Quality Management System in coordination with PKI and customer management teams. Create awareness and provide training to all employees on quality processes and programs. Responsibilities Own Quality Management System between customer, PerkinElmer, and third party service providers (TPSP). Provide leadership to affected staff to integrate the key internal and external quality systems, processes and information to ensure consistent service quality and drive excellent customer satisfaction. Drive PKI quality processes meeting customer's requirements and ensuring internal/external audit readiness. Training * Ensure that staff complete applicable training (Quality, EHSS, Security, Human Resources) on customer standards and PKI documents as appropriate to their role. * Proactively monitor staff conduct while on customer's premises and respond to any reported violation of these standards. * Ensure that staff complete the appropriate required training/role-based training prior to any services being executed. GxP Processes * Ensure that staff adhere to applicable GxP processes and procedures. * Provide support in the development and maintenance of customer controlled documents (SOPs, Protocols, Quality Manuals, Quality Agreements, List of Qualified Suppliers). * Establish, maintain, and release for staff training PKI controlled documents covering processes applicable to the customer account. * Ensure staff complete GxP work orders within scheduled timelines to prevent reporting of past due work. * Develop monthly and quarterly metrics and participate in the customer Quality metric review and governance processes. Audits and Inspections * Participate in the customer internal and external auditing and annual operational assessment processes. * Manage audit observations, findings, CAPAs, and effectiveness verification. * Ensure that staff who may participate in these audits is appropriately trained for audit response and conduct. Vendor Assessment Program * Evaluate vendors that provide materials and/or services under service agreement meeting customer's GxP asset or system requirements. * Document vendor assessment program and the results. * Ensure that all GMP subcontractors are approved by the customer and documented on the Quality Agreement. Computer Maintenance Management System (CMMS) * Ensure that staff conduct work relating to CMMS is performed per the requirements of good documentation practices and GxP regulations. Non-Conformance System * Identify, investigate, and develop CAPAs/Effectiveness Verifications for deviations relating to GxP work. * Identify and communicate to PKI management the customer any potential nonconforming event. * Provide timely rationale for why deviations occurred, any possible impact, and what processes were implemented to prevent reoccurrence. * Ensure that unexpected outcomes or systems which do not conform to customer specified conditions or SOPs shall be reported and tracked using customer's deviation system. * Ensure that staff are trained and aware of all circumstances where initiation of a deviation is required. Basic Qualification & Experience * BS Degree, in a scientific field * 8 years of applicable Quality and Compliance skills in pharma/biotech industry preferred. Preferred Qualifications: * Extensive experience in both internal and external auditing. ISO 9001:2015 Lead auditor preferred. * Proven track record of delivering continual positive improvement in systems and process * Excellent organizational, communication, and presentation skills. * Team management and staff mentoring skills. * A good balance of negotiating and influencing skills. Work Environment Laboratory and office setting. Some travel to other sites. Work closely with customer management team and laboratory personnel. Physical Requirements Ability to walk/stand up to 4 hours. Ability to lift/maneuver 25lbs packages. Ability to move throughout lab and loading dock. SDL2017

Keywords: PerkinElmer, Thousand Oaks , Sr. Quality and Compliance Specialist, Other , Thousand Oaks, California

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