ECQ LC Specialist
Newark Metro Area, NJ
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.
Required Competencies Knowledge, Skills, and 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.
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.
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.
Will likely spend 70% of their time in a laboratory environment. Will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
Ability to work safely and effectively when working alone, or working with others.