Staff Source Compliance Specialist

Johnson & Johnson•Guaynabo, PR

10d•Hybrid

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for Staff Source Compliance Specialist, located at either: Guaynabo, PR; Cornelia, GA; Raritan, NJ or San Angelo, TX. Purpose: The Staff Source Compliance Specialist, under the supervision of the Source Quality System Lead, is responsible for establishing and maintaining a robust compliance program to ensure compliance with all applicable regulatory requirements, company policies and procedures, and J&J Corporate requirements. The Staff Source Compliance Specialist will also be responsible to lead and oversee NC, CAPA, Escalations and internal/external observations activities as defined in Purchasing Control Quality Systems Procedures. The Staff Source Compliance Specialist will also act as the single point of contact (SPOC) for the Audit Readiness and Audit Support activities related to the Source Quality global team.

Requirements

A minimum of a bachelor’s degree in engineering, Applied Science or a related technical and quality field is required.
A minimum of 4 years of work experience in a highly regulated Industry is required.
Practical experience with GMP documentation and writing skills in the FDA regulated environment is required.
Strong Communications Skills in English (Written and Oral)

Nice To Haves

At least 2 years of experience in external audit readiness and management, is preferred.
Source Quality or Procurement experience is preferred.

Responsibilities

Lead and manage internal/external audit readiness activities to always ensure readiness. These activities include audit logistics, front room/back-room arrangements, identifying/preparing SME’s, support to sites during audits etc.
Partner with site leadership to support internal/external audits: e.g. Notified Body, Health Authority, Ministry of Health, FDA, Regulatory Agency, JJRC or ERC audits of the sites.
Provide timely information to support the internal/external audit/inspection process.
Ensure external audit results are reported to management having responsibility for the matters audited.
Provide daily internal/external audit/inspection communications regarding potential non-conformities or observations.
Provide guidance to prepare responses to any internal/external audit/inspection or other regulatory notification associated with Purchasing Controls.
Ensure timely and adequate responses to internal/external audit observations related to Purchasing Controls, including failure investigations, root cause analysis and correction/corrective/preventive action plans, monitor and drive on-time completion of all action plans, perform follow-up with owners, and perform effectiveness monitoring and closure.
Where appropriate, ensure compliance representation on required sector and/or enterprise teams/projects.
Support the effective deployment of J&J Quality System standards at the site.
Connect and collaborate with the compliance teams of all sites and regions.
Escalate quality issues in accordance with established procedures.
Provide routine communication, updates and escalation to site and franchise organizational management regarding compliance trends and initiatives.
Responsible for the proactive identification and alerting the management of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business.
Support implementation of new regulations and standards.
Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings.
Proactively communicate organizational and regulatory compliance related changes that may impact Purchasing Controls. Ensure feedback and alignment with said changes.
Where appropriate, ensure source compliance representation on required site teams/projects.
Establish connection and collaboration with business partners at the site (e.g. Quality Systems, Regulatory Compliance, Quality Operations, Training, and Manufacturing).
Provide/coordinate compliance education and training (QSR, ISO, etc.) to the team in support of overall education strategies.
Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001) and ensure all direct reports comply with those requirements.
Responsible for communicating business related issues or opportunities to next management level.
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed.

Benefits

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
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 placement 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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year