The Technical QA Lead reports to the Quality Manager or Manager of Training. This position is an exempt position. Fifty percent travel may be required. This is based on a scheduled need and requirement.
Expectations: The Technical QA Lead will be actively engaged with PCI Customers and with PCI work product. The Technical QA Lead will be engaged with Field Operations and Metrology Operations. The Technical QA Lead is expected to establish, maintain and drive quality standards in accordance with corporate objectives across all business units. This individual is expected to demonstrate a strong knowledge of quality systems in the Pharmaceutical/Biotechnology industry and have a strong grasp on effectively managing multiple priorities. CCMS/CMMS (RAM), Training Database, and other Microsoft products (Excel, Word, PowerPoint) will be utilized frequently and must be used effectively and efficiently by the Technical QA Lead. The Technical QA Lead will have a strong technical background in calibration and metrology technology and practices in order to evaluate and provide corrective training on calibration execution by other associates.
Responsibilities:
Technical Quality Deliverables for Customers:
o Review and engagement with PCI Customer Compliance Metrics and Scorecards
o Engagement with PCI Data Analyst and supporting review and deliverables of PCI work product
o Support on PCI Capital Project Revenue Programs in regard to quality representations, audits, and support
Quality Systems
o Maintain and continuously improve the Quality System including the Quality Manual
o Evaluate, document, and report progress in meeting quality objectives
o Promptly address any customer complaints and assist in implementing customer solutions
o Manage the corporate document control systems
o Ensure compliance of internal programs including change and documentation control processes
o Identify areas for continuous improvement initiatives
ISO 17025
o Own the accreditation process by hosting annual audits and coordinating with internal managers accreditation scope changes
Training Systems
o Manage the corporate training database including system administration and end-user training
o System administration includes uploading policies and other documents, adding/removing courses and users and ensuring company-wide trainings are up-to-date
o Where applicable, provide field training to PCI associates in proper execution of technical calibration activities.
Audits and Investigations
o Manage the internal audit program of the quality system
o Complete internal and external quality assessments. This will also include Field Audits
o Audit and Inspection programs within PCI training programs
o Handle client audits; both physical and paper audits
o Perform field audits of technical staff to assess proper execution of field calibrations and adherence to PCI policies and procedures as well as GxP practices
Safety
o Serve as PCI's Safety Officer and main point of contact for all safety related matters
o Lead the Safety Committee and present valuable information back to senior leaders o Execute safety initiatives, handle incident reports, and accurate OSHA logs
o Provide field evaluation of safety practices at PCI project sites to confirm adherence to PCI and Client safety program requirements.
Special Skills Required:
Ø Self motivated individual who exhibits a professional demeanor, and enthusiasm
Ø Excellent organizational, analytical, problem solving and team player skills
Ø Strong interpersonal skills to interact confidently with clients and employees
Ø Possess excellent oral and written communication skills
Ø High attention to detail
Ø Effective organization and prioritization skills
Ø Ability to multitask
Ø Travel to projects in other geographical locations
Ø Join PCI Business Review Meetings when applicable
Ø Strong computer and database skills
Ø Experienced with Microsoft Office products
Education & Experience Required:
A four-year degree in Life Sciences or Quality Assurance, or other related field and six years of industry experience (or the equivalent combination of education and experience). Extensive relational database experience is also required.
PCI is proud to serve pharmaceutical, biotechnology, medical device, and clinical research industries nationwide by providing calibration, commissioning and consulting solutions. At PCI, calibrations are performed by highly technical, cGMP/GLP-trained personnel who are knowledgeable in quality guidelines enforced by the FDA, EPA and ISO/IEC 17025:2017. PCI is an FCX Performance Company and a Subsidiary of Applied Industrial Technologies (NYSE: AIT); a leading industrial distributor that offers more than 6.5 million parts to serve the needs of MRO and OEM customers in virtually every industry.
Founded in 1923, Applied® provides engineering, design and systems integration for industrial and fluid power applications, as well as customized mechanical, fabricated rubber and fluid power shop services. Applied also offers storeroom services and inventory management solutions that provide added value to our customers.
