Senior QA Specialist, Compliance

Johnson & Johnson•Wilson, NC

13h•Onsite

About The Position

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: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Wilson, North Carolina, United States of America Job Description: The purpose of this document is to outline the job description of the QA Specialist at Janssen Biotech, Inc in Wilson, North Carolina. The QA Specialist reports to the Senior Manager, Quality Assurance. Essential Job Duties and Responsibilities QA Specialist, Compliance This position is responsible for ensuring compliance with regulatory requirements and company policies following current Good Manufacturing Practices, Johnson & Johnson Policies and internal procedures through the following duties and responsibilities: Responsible for execution of Risk Management Program through the identification, assessment, and management of quality risks. Implement appropriate preventive measures and corrective actions to minimize potential quality issues. Implement and execute the Notification to Management/Escalation procedures as defined by J&J standards and procedures. Facilitate timely resolution through coordination with relevant department and teams. Responsible for development and implementation of Data Integrity Program for the BioNC site in alignment with J&J standards and procedures. Responsible for preparation, review and submission of data reported to Health Authorities including BPDRs, Inspection responses and review of Regulatory submission documents. Collaborates and contributes to Site Inspection Readiness Activities, including global internal audits and assessments. Collaborate with cross-functional teams (Operations, Engineering & Maintenance, MSAT, QC, etc) to address quality issues. Provides support to documentation review through evaluation and approval of documentation related to regulatory submissions, standard operating procedures (SOPs), and quality management systems to ensure accuracy and compliance. Additional Job Duties and Responsibilities: Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standards. Partners with other Departments to ensure that compliance systems are implemented in an efficient manner. Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site. Carries out tasks related to the administration of site nonconformance management, change control and training systems and its applicable Electronic Tracking System (ETS). Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site.

Requirements

Bachelor's degree in a scientific or engineering discipline is required.
Minimum six (6) years experience working within the biological and/or pharmaceutical industry in a quality, manufacturing, or compliance role.
Strong knowledge of relevant regulations and quality management principles, such as Good Manufacturing Practices (GMP), ICH, and ISO standards.
Understanding and experience in application of global regulatory (FDA, EMA, etc.) guidelines in a biological or pharmaceutical manufacturing environment.
Experience with regulatory inspections and response to observations.
Proficiency in risk management methodologies such as FMEA.
An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
Proven ability to manage multiple priorities and work independently with minimal supervision.
Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
Ability to build and nurture strong and positive relationships.
The ability to work in a team environment and interact with all levels of the organization.
Business Alignment
Business Savvy
Coaching
Communication
Compliance Management
Continuous Improvement
Fact-Based Decision Making
Human-Centered Design
ISO 9001
Issue Escalation
Problem Solving
Quality Control (QC)
Quality Management Systems (QMS)
Quality Standards
Regulatory Environment
Standard Operating Procedure (SOP)

Responsibilities

Responsible for execution of Risk Management Program through the identification, assessment, and management of quality risks.
Implement appropriate preventive measures and corrective actions to minimize potential quality issues.
Implement and execute the Notification to Management/Escalation procedures as defined by J&J standards and procedures.
Facilitate timely resolution through coordination with relevant department and teams.
Responsible for development and implementation of Data Integrity Program for the BioNC site in alignment with J&J standards and procedures.
Responsible for preparation, review and submission of data reported to Health Authorities including BPDRs, Inspection responses and review of Regulatory submission documents.
Collaborates and contributes to Site Inspection Readiness Activities, including global internal audits and assessments.
Collaborate with cross-functional teams (Operations, Engineering & Maintenance, MSAT, QC, etc) to address quality issues.
Provides support to documentation review through evaluation and approval of documentation related to regulatory submissions, standard operating procedures (SOPs), and quality management systems to ensure accuracy and compliance.
Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standards.
Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
Carries out tasks related to the administration of site nonconformance management, change control and training systems and its applicable Electronic Tracking System (ETS).
Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site.

Benefits

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 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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year