Senior Operations Analyst

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

Job Function:

Supply Chain Deliver

Job Sub Function:

Warehouse & Distribution

Job Category:

Professional

All Job Posting Locations:

Somerset, 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

The Specialist – Investigations is responsible to investigate, document and bring to conclusion the outcome of product/processing related incidents, deviations or documentation errors reported under the guidance of the Sr Operations Support Supervisor – Investigations and the Sr Operations Support Manager – Investigations. Apply investigative tools and techniques to identify and evaluate the cause of an event including root cause analysis, impact or risk analysis, corrective and preventative actions and monitoring efficiency of implemented actions to follow the FDA and other Regulatory cGMPs investigation requirements/guidelines. Recommends, proposes, and formalizes alternatives for the improvement of processes, utilities and systems.

Key Responsibilities:

• Responsible for thoroughly investigating events as it relates to deviations or documentation errors and applying a science-based approach to accurately, correctly and timely document the final report applying appropriate investigation techniques and/or tools.

• Reviews and uses the established follow-up mechanism to ensure that applicable investigations are initiated, timely completed, final reports issued and approved by QA.

• Evaluates and discusses the impact of the reported events to ensure that its effect on previously approved product has been considered as part of the investigation process and that actions are identified to prevent its recurrence.

• Reviews and evaluates each event under investigation against the applicable metrics defined/implemented to monitor the effectiveness of corrective and/or preventive actions and communicates results to site management on the established frequency or as agreed upon.

• Maintains an updated knowledge of the cGMP regulations and FDA/Other Regulatory Guidelines and uses those principles in the investigation process and final report issuance. Keeps abreast of the site products, quality systems, controls, projects and processes to ensure that investigations outcomes are consistent with the existing operating environment.

• Defines the investigation data needed from the applicable functional areas to prepare and revise the documents involved in the assigned investigations in order to track and ensure that these are completed on a timely basis to effect product disposition.

• Provides technical support to Area Managers and Supervisors in the GMP related aspects associated to the manufacturing/packaging/laboratory processes, e.g., investigations, complaints, deviations, CAPAs, changes, APRs.

• Maintains communication with QA at other Janssen sites and external customers/contractors as required to ensure that, as applicable, extended investigations and/or CAPAs are understood, timely completed and followed up.

• Participates in the writing, review or revision of procedures to assure these are consistent with current practices, cGMPs, guidelines and policies, industry practice and trends.

• Maintains management advised of events that will impact the quality and/or timely disposition of products. Participates or lead Cross Functional Investigations (CFIs), as required. Provide training in SOPs related to the QA area to colleagues from other functional areas, as required. Issue investigation reports, complaints follow-up and applicable monthly monitoring progress reports for the site.

• Utilizes available methodologies or techniques and statistical analysis tools to conduct investigations.

Qualifications

Education:

• A minimum Bachelor’s and/ or equivalent degree required; master’s degree of Science in Chemistry, Biology, Microbiology, Pharmacy or Engineering or related field is required.

Experience and Skills:

Required:

• A minimum of five (5) years of experience in related areas in the pharmaceutical, biotechnology or related industry.

• Expert understanding of cGMPs, Good Documentation Practices, and Regulations.

• Ability to apply statistical techniques to track and analyze process performance.

• Outstanding problem solving and analytical skills.

• Working Knowledege of solids

• Proficient knowledge of FDA regulations

• Proficient in the use of MS Office applications, TrackWise system, ePES/SAP, Minitab, Document Control systems, among other applications.

• Proficiency in evaluation of analytical results, data, experiments, professional literature and technical manuals.

Preferred:

• Experience in parenteral manufacturing is preferred

• Knowledge of computer systems GMP requirements for Part 11 compliance.

Technical knowledge in pharmaceutical manufacturing processes, technologies and processing equipment

Other:

• Ability to travel up to 10% of the time ; international and domestic

• Proficient in English(oral and written)

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Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$77,000.00- $124,000.00 USD

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are 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. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time – 40 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 Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. #J-18808-Ljbffr