AddressDescription
Johnson & Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Control Analyst II!
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/ .
The Quality Control Analyst II 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 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.
Qualifications
Education
- Bachelor's degree and/or equivalent degree required; preferably in Science or related field.
Experience and Skills:
Required:
- A minimum two (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.
Preferred:
- Experience with Karl Fischer analysis.
- Experience with Dissolution apparatus and UV.
- Experience authoring Standard Operating Procedures.
Other:
- This position will be located in Titusville, NJ and may require up to 10% domestic or international travel.
The anticipated base pay range for this position is $61,000 to $97,750.
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be 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.
– Vacation – up to 120 hours per calendar year
– Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
– Holiday pay, including Floating Holidays – up to 13 days per calendar year
– Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on May 22, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
