Job Function:
Quality
Job Sub Function:
Supplier Quality
Job Category:
Professional
All Job Posting Locations:
Cornelia, Georgia, United States of America, Guaynabo, Puerto Rico, United States of America, Raritan, New Jersey, United States of America, San Angelo, Texas, United States of America
Job Description:
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.
You will be responsible for:
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.
Qualifications:
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.
At least 2 years of experience in external audit readiness and management, is preferred.
Source Quality or Procurement experience is preferred.
Strong Communications Skills in English (Written and Oral)
The expected base pay range for this position is $94.000 to $151.800.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
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)).
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 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 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: -
#LI-Hybrid
Required Skills:
Preferred Skills:
Coaching, Communication, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Data Compilation, Econometric Models, ISO 9001, Issue Escalation, Performance Measurement, Problem Solving, Quality Control (QC), Quality Standards, Standard Operating Procedure (SOP), Technologically Savvy, Vendor Selection
