Purpose of the Position: The ECQ LC Specialist supports the successful operation of Waters and Agilent HPLC, UPLC and LCMS systems through interaction with internal customers and external service providers. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems associated with HPLC, UPLC and LCMS systems. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization. The incumbent may be asked to lead small to medium sized projects in their area of responsibility, and will be called upon to create and revise work processes or procedures that impact their immediate function or organizational unit. The incumbent may be involved with writing deviations, investigations and supporting the implementation of change controls.
Essential Functions: 1) Operational Activities a. Executes HPLC, UPLC and LCMS calibrations, maintenances, repairs, and requalification activities in laboratory areas. b. Demonstrated proficiency for calibration, preventative maintenance, and qualification functions as related to Waters and Agilent HPLC, UPLC, and LCMS systems. c. Coordinates/supervises LC vendors for calibration, preventative maintenance, and qualification functions. d. Reviews and approves LC vendor executed calibration, maintenance, repair, and qualification records for accuracy, completeness and compliance to Client standards. e. Works closely with, and enters data into the site CMMS system. f. Ensures all LC calibration, PM, and qualification records are filed appropriately after approval. g. Writes and supports deviations and investigations that result from LC qualification failures, if applicable, along with developing and supporting the implementation of corrective and preventative actions. h. Support the development, revision and review of written LC procedures for calibration, preventive maintenance and requalification of equipment. i. Support the development, review and approval of LC calibration and maintenance plans in site CMMS system. j. Supports the execution of LC qualifications and process improvement studies. k. Adheres to all policies and procedures which govern the ECQ team and the LC equipment they manage to ensure compliance is held to the highest standard.
2) Promotes and provides excellent customer service and support a. Regularly reviews, prioritizes and promptly responds to customer LC maintenance, repair and support requests. b. Provides technical support and guidance on calibration and maintenance issues. Interfaces with customers to ensure expectations are being met. c. Maintains a positive relationship with all the members of the ECQ department and site customers while promoting a positive team environment.
3) Inventory Management a. Work with planning group to ensure CMMS system is updated as LC calibration, maintenance and requalification activities are performed.
4) Regulatory Responsibilities a. Maintains all required Corporate, Facilities and EHS training as required. b. Adheres to all safety procedures and hazard communication. c. May be called upon to act as Subject Matter Expert in both internal and regulatory audits.
Required Competencies-Knowledge, Skills, and Abilities: Knowledge, Skills & Abilities: Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. Advanced knowledge of Waters and Agilent HPLC, UPLC and LCMS systems. Strong written and verbal communication skills. Excellent interpersonal skills with experience dealing with a diverse workforce. Strong multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously. Highly proficient computer skills in Microsoft Office Suite Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business. Working knowledge of inventory management systems (CMMS), mainly Blue Mountain RAM. Ability to interact effectively with laboratory, QA, and Facilities groups.
Competencies: Professional Knowledge Problem Solving Team Player / Building Relationships Multi-tasking Customer Focus Action and detail oriented Active Listening
Education & Experience: BS in Engineering or Science related discipline preferred. Minimum 5 years of experience performing qualification, maintenance and repairs of Waters and Agilent LC equipment in FDA-regulated industry required. LC instrumentation background and experience in laboratory operations. Knowledge of cGMP in the pharmaceutical industry. Excellent computer skills including knowledge of calibration management. Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently. Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required Experience writing and supporting deviations and investigations preferred.
Working Conditions: Physical / Mental Demands: Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs Ability to sit, stand, walk and move within workspace for extended periods Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.