Senior QA Specialist, Compliance

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

Minimum Qualification

• Bachelors 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. (QA Specialist Compliance)

• Proficiency in risk management methodologies such as FMEA.

Key Competencies - Other requirements

• 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.

Required Skills:

Preferred Skills:

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)

The anticipated base pay range for this position is :

$94000.00 - $151800.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).



This position is eligible to participate in the Companys 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

For additional general information on Company benefits please go to: - Experience:

Senior IC