ECQ LC Specialist
Newark Metro Area, NJ
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 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.
Team Player / Building Relationships
Action and detail oriented
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.