"Alerted.org

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, Release

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 Quality Assurance Batch Record Review and Approval for batch release, including Certificate of Analysis preparation, to ensure compliance with GMP requirements.

+ Responsible for Quality review and approval of Raw Materials and Excipients for release to ensure compliance with GMP requirements.

+ Responsible for completion of tasks and projects related to the management of Quality Assurance including change control, nonconformance investigation, incoming material release, batch release

+ 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

+ 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.

+ Specific Experience as the person responsible for Batch Release (QA Specialist, Release)

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 :

$94,000.00 - $151,800.00

Additional Description for Pay Transparency:

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)).

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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