QC Analyst (Analytical Instrument and Lab Systems - Empower (Waters) chromatography data system (CDS))

Johnson & Johnson • Wilson, NC

2d • Onsite

About The Position

We are currently seeking a highly qualified individual to join our team as a QC Analyst (Analytical Instrument and Lab Systems) at our new Biotherapeutics Manufacturing facility in Wilson, North Carolina (BioNC). In this key role, you will be responsible for laboratory equipment lifecycle management, CSV support, and introducing & maintaining lab systems. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

Requirements

• Bachelor’s Degree in Chemistry, Biochemistry, Micro or science related field with 2+ years related experience in biopharmaceutical or pharmaceutical industry. And/or an equivalent combination of education and experience.
• Working knowledge of regulatory requirements, policies and guidelines.
• Experience with Quality Control document reviews and regulatory inspection processes.
• Working knowledge of laboratory systems.
• Hands-on experience administering and/or using Empower (Waters) CDS in a GMP QC environment (e.g., project setup, processing, reporting, user management, audit trails, and data integrity controls).
• Strong technical knowledge in and experience with QC analytical equipment is required.
• Knowledge of cGMP regulations and FDA/EU guidance is required.
• An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex quality concepts to stakeholders at all levels.
• Proven ability to manage multiple priorities and work independently with minimal supervision.
• Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
• Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
• The ability to work in a team environment and interact with all levels of the organization.

Responsibilities

• Serve as a site SME for Empower (Waters) chromatography data system (CDS), supporting implementation, validation (CSV), user access, troubleshooting, and continuous improvement.
• Participate in activities to introduce and sustain laboratory technologies and computer-based applications (eLIMS/iLABS, SDMS, Empower, SoftMax Pro) to improve laboratory efficiency and promote a culture of Innovation.
• Participate in the qualification of analytical equipment for related testing functions, for example, IQ/OQ/PQ of HPLC, Spectrophotometry, Endotoxin, Cell Culture and Total Organic Carbon equipment.
• Author SOP’s, Work Instructions and protocols.
• Responsible for the quality control laboratory equipment lifecycle management and CSV support.
• Interact with the QC Global organization for the different center of excellence for equipment and information technologies.
• The resolution of unexpected complex compliance or lab instrument and system issues as they arise.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level