Quality Control Analyst I
Johnson & Johnson Innovative Medicine · Titusville, NJ · Yesterday
On-siteQuality Assurance$54k–$87k/yrFull-time
About the role
Conducts analytical testing of stability samples according to testing schedules in a productive and efficient manner.
Maintain a safe work environment align with environmental, health, and safety regulations.
Supports investigations and resolution of laboratory nonconformances.
May occasionally assist the supervisor in prioritizing for the functional QC laboratory.
Supports the development and execution of CREDO action plans and initiatives.
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.
- Absorb and execute internal audits.
- Complete corrective and preventative actions (CAPA) as assigned.
- Support investigations and resolution of laboratory nonconformances.
- Make contributions to, and occasionally lead, continuous improvement teams.
- Interact and involve with global project teams.
- Provide input to functional laboratory meetings and take actions as a QC representative at cross-functional meetings.
- Occasionally assist the supervisor in prioritizing for the functional QC laboratory.
- Support the development and execution of CREDO action plans and initiatives.
Requirements
- A minimum one (1) year of experience in a GMP-regulated, science-related field.
- 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.
- Has basic root cause analysis skills. Works directly with supervision for resolution of complex issues.
Qualifications
- 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.
- Has basic root cause analysis skills. Works directly with supervision for resolution of complex issues.
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
- Techonologically Savvy
Pay
$54,000.00 - $87,400.00
Benefits
- Consolidated Retirement Plan (pension)
- Savings Plan (401(k))
- Long-term incentive program
- 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
- 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
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year