Experienced Analyst, QC

Johnson & Johnson Innovative Medicine • Hopewell Township, NJ

1d • $79,000 - $127,650 • Onsite

About The Position

We are seeking a highly skilled and experienced analyst whose primary responsibilities will include conducting comprehensive data reviews and approvals on stability testing in accordance with analytical methodologies. Additionally, this individual should be prepared to perform select analytical tests independently, adhering to established testing schedules to ensure seamless and efficient workflow. We require a candidate who demonstrates both exceptional productivity and meticulous attention to accuracy across all tasks.

Requirements

• Bachelor's degree and/or equivalent degree required; preferably in Science or related field.
• A minimum four (4) 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 advanced testing within the functional laboratory, using HPLC and/or UPLC, using the Empower software.
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to QC laboratory.
• Knowledge of compendial (USP, EP, JP, etc.) requirements.
• Skilled technical writing skills.
• Ability to manage an individual project with mentorship from supervision/management.
• Ability to review testing documentation, daily testing, method transfer protocols
• 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 root cause analysis skills.
• Works directly with supervision for resolution of complex issues.
• Demonstrates a high level of efficiency and proficiency in performing analytical testing in compliance with all regulations.

Nice To Haves

• Experience with Karl Fischer analysis preferred.
• Experience with Dissolution apparatus and UV preferred.
• Experience authoring Standard Operating Procedures preferred.
• Utilize electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing preferred.

Responsibilities

• Review / Approve laboratory data 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.
• 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.
• Trend analytical data generated by other analysts.

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
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• consolidated retirement plan (pension)
• savings plan (401(k))

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level