Analyst 1 Stability QC

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 https://www.jnj.com

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

We are searching for the best talent for Analyst 1 Stability QC to be in Titusville, New Jersey.

The QC Analyst I conducts analytical testing of stability samples according to testing schedules in a productive and efficient manner.

Key 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 troubleshoot methods where required with some assistance.

• Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing

• Assist the execution of internal audits

• Maintain individual training completion in a compliant state

• Support investigations and resolution of laboratory nonconformances

• Make contributions to continuous improvement teams.

• Provide input to functional laboratory meetings and take actions as a QC representative at cross-functional meetings

• Support the development and execution of CREDO action plans and initiatives

Education

• Bachelor's degree and/or equivalent degree required; preferably in Science or related field

Experience and Skills:

Required:

• At least 2 years of experience in a GMP-regulated, science-related field

• Basic knowledge of analytical technologies used in the QC laboratory

• Skilled in performing intermediate and some advanced testing within the functional laboratory, using HPLC and/or UPLC

• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to QC laboratory

• Ability to participate in projects 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)

• Performs basic instrument troubleshooting and has basic root cause analysis skills. Works directly with supervision for resolution of complex issues.

Preferred:

• Experience with Karl Fischer analysis

• Experience authoring Standard Operating Procedures

• Experience in HPLC or UPLC

• Basic knowledge of compendial (USP, EP, JP, etc.) requirements

• Basic technical writing skills

· The expected base pay range for this position is $28 - $39 / hr

· The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

· This position is overtime eli