Analyst Quality Control

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Malvern, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

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

We are searching for the best talent for Analyst Quality Control

The QC Analyst conducts biochemical, microbiological, and/or general chemical testing of raw material, in-process, or final product samples submitted to the QC laboratories. The position requires testing to be completed in compliance with all applicable procedures, standards and GMP regulations.

Physical Location of Role: Malvern, PA

Tasks/Duties/Responsibilities

• Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations
• Conducts analytical methodologies and testing within the QC laboratory
• Performs peer review of laboratory data
• Utilize electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing
• Maintains knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory
• Follows compendial (USP, EP, JP, etc.) requirements and standards for QC testing
• Conducts general housekeeping activities and supply ordering/receipt
• Supports 24 hr manufacturing schedule
• Maintains inspection readiness system and activities for the site.
• Proactively evaluates and facilitates remediation of compliance risks.
• Participates in quality audits, Inspection activities, and responses.
• Remains current in skills and industry trends.
• Facilitates or participates in any and all required meetings related to quality control.
• Carries out duties in compliance with all local, state, federal, and global regulations and guidelines.
• Complies with all company and site policies standards and procedures.
• Successfully completes regulatory and job training requirements.
• Perform Technical writing (SOP, TMD, Protocol/Validation Reports).
• Supports calibration and/or preventative maintenance.
• Execute process excellence tools and methodologies.
• Perform project management functions.
• Apply statistical concepts to laboratory data.
• Support of New Product Initiative (NPI).
• Support QC invalid assay records and non-conformance investigations.
• Support change management processes including formal change controls by evaluating the proposed changes, documenting impact assessments, and providing feedback on implementation plans.
• Train new QC personnel.

Required Minimum Education:

BA/BS Other: BA/BS

Equivalent Required Years of Related Experience: 0-2 years

Required Competencies, Knowledge, Skills and Abilities:

• Level appropriate knowledge of analytical technologies used in the QC laboratory
• Skilled in performing basic testing within the QC laboratory
• Experience, knowledge and understanding using Good Laboratory Practices (GLP) and basic knowledge of current Good Manufacturing Practices (cGMP) related to the QC laboratory
• Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)
• Makes GMP laboratory decisions both independently and with guidance from QC supervision
• Performs independent troubleshooting and has basic root cause analysis skills. Works directly with supervision for resolution of complex issues
• May occasionally assist the supervisor in establishing priorities within the functional
• Works with supervision on routine tasks. Does not perform non-routine tasks. Begins to demonstrate technical skills to perform job functions. Learning departmental operations. Works with the assistance/support of senior levels in QC functions. Suggests basic improvements on work assignments. Escalates issues to management in a timely manner.

Physical Requirements/ Working Conditions

• Required to work with chemical and biological substances on a daily basis
• Required to work on feet or seated for extended periods of time in a laboratory setting
• Requires sufficient vision to adequately perform visual inspections of materials (color, appearance, particles, etc.) and to document observations during laboratory testing
• Occasionally required to lift up to 20 pounds

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. 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 and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource

#LI-Onsite

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, ISO 9001, Persistence and Tenacity, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technologically Savvy