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 **Job Function:** Supply Chain Manufacturing **Job Sub** **Function:** Manufacturing Process Improvement **Job Category:** Professional **All Job Posting Locations:** Gurabo, Puerto Rico, 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 https://www.jnj.com/innovative-medicine . 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) 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 .] 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 ( ra-employeehealthsup@its.jnj.com ) or contact AskGS to be directed to your accommodation resource.