QC Analyst II

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

4d•$65,000 - $104,650•Onsite

About The Position

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

Requirements

Bachelor's degree and/or equivalent degree required; preferably in Science or related field.
At least 2 years of experience in a GMP-regulated, science-related field.
Detailed 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.
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 makes 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.

Nice To Haves

Experience with Karl Fischer analysis preferred.
Experience with Dissolution apparatus and UV preferred.
Experience authoring Standard Operating Procedures preferred.

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 high level of understanding of analytical test methods with ability to independently implement and troubleshoot methods where required
Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing
Complete analytical method qualification, validation, and transfer with mentorship
Instrument Calibration and/or Preventative Maintenance
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

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 period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

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