Quality Control Analyst I

Biopharma Careers; Titusville (FL); On-site; USD 54,000 - 87,000; Full time

Benefits offered by this job

Vacation –120 hours per calendar year

Sick time – 40 hours per calendar year

Holiday pay – 13 days per calendar..

Careful with multiple benefits

Job summary

Johnson & Johnson, a leading healthcare company, is seeking a Quality Control Analyst I to conduct analytical testing of stability samples in a GMP-regulated environment. You will use LIMS, MES and Empower systems, perform method qualification, and support internal audits while working within a cross-functional QC team.

The role emphasizes compliance with cGMP, data integrity, and contributing to continuous improvement initiatives across global projects.

Qualifications

• A minimum one (1) year of experience in a GMP-regulated, science-related field.
• Basic knowledge of analytical technologies used in the QC laboratory.
• Skilled in performing basic and some intermediate testing within the functional laboratory, using HPLC and/or UPLC.
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to QC laboratory.
• Basic knowledge of compendial (USP, EP, JP, etc.) requirements.
• Basic technical writing skills.
• Ability to manage an individual project with mentorship from supervision/management.
• 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).
• Ability to make GMP laboratory decisions both independently and with occasional mentorship from QC Supervisor.
• Performs independent troubleshooting and has basic root cause analysis skills. Works directly with supervision for resolution of complex issues.

Responsibilities

• Perform analytical testing in compliance with all applicable procedures, standards and GMP regulations as well as all local, state, federal and international regulations and guidelines (FDA, EPA, DEA, OSHA, etc.).
• Maintain a safe work environment align with environmental, health, and safety regulations.
• Demonstrate a moderate level of understanding of analytical test methods with ability to implement and troubleshoot methods where required, with occasional guidance from a senior Analyst / QC Supervisor.
• Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing.
• Complete analytical method qualification, validation, and transfer with mentorship.
• Assist the execution of internal audits.
• Maintain individual training completion in a compliant state.
• Complete corrective and preventative actions (CAPA) as assigned.
• Support investigations and resolution of laboratory nonconformances.
• Make contributions to, and occasionally lead, continuous improvement teams. Interaction and involvement with global project teams.
• Provide input to functional laboratory meetings and take actions as a QC representative at cross-functional meetings.
• May occasionally assist the supervisor in prioritizing for the functional QC laboratory.
• Support the development and execution of CREDO action plans and initiatives.

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

Tools

LIMS

MES

Empower

LES

Excel

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive,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

Titusville, New Jersey, 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

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Quality Control Analyst I.

Purpose

Conducts analytical testing of stability samples according to testing schedules in a productive and efficient manner.

Responsibilities

• Perform analytical testing in compliance with all applicable procedures, standards and GMP regulations as well as all local, state, federal and international regulations and guidelines (FDA, EPA, DEA, OSHA, etc.).
• Maintain a safe work environment align with environmental, health, and safety regulations.
• Demonstrate a moderate level of understanding of analytical test methods with ability to implement and troubleshoot methods where required, with occasional guidance from a senior Analyst / QC Supervisor.
• Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing.
• Complete analytical method qualification, validation, and transfer with mentorship.
• Assist the execution of internal audits.
• Maintain individual training completion in a compliant state.
• Complete corrective and preventative actions (CAPA) as assigned.
• Support investigations and resolution of laboratory nonconformances.
• Make contributions to, and occasionally lead, continuous improvement teams. Interaction and involvement with global project teams.
• Provide input to functional laboratory meetings and take actions as a QC representative at cross-functional meetings.
• May occasionally assist the supervisor in prioritizing for the functional QC laboratory.
• Support the development and execution of CREDO action plans and initiatives.

Qualifications / Requirements

• A minimum one (1) year of experience in a GMP-regulated, science-related field.
• Basic knowledge of analytical technologies used in the QC laboratory.
• Skilled in performing basic and some intermediate testing within the functional laboratory, using HPLC and/or UPLC.
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to QC laboratory.
• Basic knowledge of compendial (USP, EP, JP, etc.) requirements.
• Basic technical writing skills.
• Ability to manage an individual project with mentorship from supervision/management.
• 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).
• Ability to make GMP laboratory decisions both independently and with occasional mentorship from QC Supervisor.
• Performs independent troubleshooting and has basic root cause analysis skills. Works directly with supervision for resolution of complex issues.

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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

#LI-Onsite

Required 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

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

Pay and Benefits

The anticipated base pay range for this position is : $54,000.00 - $87,400.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to:https://www.careers.jnj.com/employee-benefits