QC Senior Scientist Microbiology and Analytical Investigations Full-time

QC Senior Scientist Microbiology and Analytical Investigations

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.

Responsible for performing CAPA Microbiology and Analytical investigations identified in the Quality Control (QC) area, including, but not limited to, suspect test results for Out of Trend (OOT), Out of Specifications (OOS) and Out of Limit / Level events, and supplier related investigations for microbiological, chemical, and physical testing of raw materials, drug products, intermediaries and utilities (i.e. water, etc.) according with internal and compendia specifications. Assures compliance to all QC policies, procedures and systems to ensure the timely release of high-quality products in support to the supply chain process. Subject matter expert of microbiological tests and knowledge of analytical tests performed at the QC area. Serves as back-up of the QC Lab Services supervisor in different forums pertaining to the CAPA process.

You will be responsible for:

• Leading CAPA investigations and acts as record owner.
• Participation in multidisciplinary meetings to evaluate events that may need to be investigated and provide status of investigation records.
• Completing risk assessment following current CAPA procedures.
• Investigating and completing the record stages on a timely manner.
• Providing rationale to proceed with the usage of the product/lot/material.
• Performing root cause analysis using applicable tools to identify the immediate cause or root cause of the event, as applicable based on the investigation level and impact category.
• Completing the investigation record in accordance to local and global procedures and enforcing the on-time closure of records.
• Acting as owner of CAPA system records, such as Corrections and CAPA actions.
• Performing evaluations and acting as responsible for the completion of risk assessments and documents generation and revisions to support QC operations.
• Expertise of the operation of microbiology laboratory equipment required for microbiological tests and knowledge of the chemical laboratory test equipment.
• Participating in the internal and external forums as QC representative to support base business.
• Actively participating in projects, safety and environmental, GMPs, SOPs trainings and others as required and/or special activities that the company promotes to foster employee involvement and their professional development/growth such as environmental/safety/GMP improvement project to simplify, reduce, minimize or eliminate environmental or compliance aspects at the job area.
• Actively participating in the generation and analysis of QC performance metrics.
• Supporting Quality Control Laboratory Internal and External Audits and Inspections.
• Supporting personnel training.
• Temporarily supervisor activities to re-place the supervisor during leave licenses.

Qualifications / Requirements:

• Bachelor's degree in sciences in Microbiology, Biology or Chemistry is required. Master's degree is preferred.
• A minimum of 4 years of experience in laboratory investigations is required.
• A minimum of 2 years in Microbiology Investigations is required.
• Certification in the management of CAPA investigations is preferred.
• Certification in Root Cause Analysis tools is preferred.
• Knowledge of cGMP's and compliance is required.
• Statistical Analysis Experience using Microsoft Excel, Minitab etc. software is preferred.
• Computer and Software skills is required.
• LIMS system basic knowledge is preferred.
• Expertise knowledge of Microbiology with Technical knowledge Chemistry is required.
• Knowledge of basic sample preparation techniques is preferred.
• General knowledge of USP/EP/JP/ChP/ACS compendia general methods and techniques is preferred.
• Knowledge of techniques such as HPLC, GC, UV-Visible spectrophotometer, FTIR, TOC, wet chemistry, culturing, biochemical, microscopy, sterility, endotoxin and environmental monitoring is preferred.
• Understand impact of laboratory performance on supply chain and business results is required.
• Bilingual (English & Spanish) is required.
• Availability to work overtime and weekends is required.
• Availability to travel up to 10% is required.

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.