Johnson & Johnson is seeking a QC Analyst (Analytical Instrument and Lab Systems) for the new Large Molecule Drug Substance Manufacturing facility in Wilson, North Carolina (BioNC). This role covers laboratory equipment lifecycle management and CSV support, among other duties.
Job Function : Quality
Job Sub Function : Quality Control
Job Category : Professional
We are looking for a highly qualified individual to join our team in this key role. You will contribute to laboratory equipment lifecycle management, regulatory compliance, and continuous improvement as part of our Innovative Medicine program.
Learn more at https : / / www.jnj.com / innovative-medicine
Essential Job Duties and Responsibilities :
- Participate in the qualification of analytical equipment for related testing functions, including IQ / OQ / PQ of HPLC, spectrophotometry, endotoxin, cell culture, and Total Organic Carbon equipment.
- Author SOPs, Work Instructions, and protocols.
- Responsible for the quality control laboratory equipment lifecycle management and CSV support.
- Participate in activities to introduce technologies and computer-based applications at a new site (e.g., eLIMS / iLABS, SDMS, Empower, SoftMax Pro) to improve laboratory efficiency and promote a culture of innovation.
- Interact with the QC Global organization for center of excellence in equipment and information technologies.
- Resolve unexpected complex compliance or lab instrument and system issues as they arise.
Qualifications :
Bachelor's Degree in Chemistry, Biochemistry, Microbiology, or a related science field with 4+ years of related experience in biopharmaceutical or pharmaceutical industries, 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.Strong technical knowledge and experience with QC analytical equipment.Knowledge of cGMP regulations and FDA / EU guidance.Other Requirements :
An unquestionable level of integrity and commitment to operating ethically and within regulatory requirements.Excellent communication and interpersonal skills, with the ability to 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.Ability to work in a team environment and interact with all levels of the organization.Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to protected characteristics. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an inclusive interview process. If you require accommodation during the interview process, please contact us via https : / / www.jnj.com / contact-us / careers or AskGS to be directed to your accommodation resource.
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