Sr Specialist, CS Compliance
Apply NowCompany: Johnson and Johnson
Location: Raritan, NJ 08869
Description:
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:
Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description:
Johnson and Johnson is recruiting for a Senior Specialist, Controlled Substance Compliance, located in Raritan, NJ, or Titusville, NJ!
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/.
The Senior Specialist, Controlled Substance Compliance, is responsible for handling of the Controlled Substance (CS) program for the Stability Laboratories. This position will assure the overall company compliance within the established GMP guidelines/Controlled substances, corporate standard operating procedures, policies, rules and regulations.
Key Responsibilities:
Education:
Required:
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
The anticipated base pay range for this position is :
$91,000-$147,200
Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be 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. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits 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.
Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description:
Johnson and Johnson is recruiting for a Senior Specialist, Controlled Substance Compliance, located in Raritan, NJ, or Titusville, NJ!
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/.
The Senior Specialist, Controlled Substance Compliance, is responsible for handling of the Controlled Substance (CS) program for the Stability Laboratories. This position will assure the overall company compliance within the established GMP guidelines/Controlled substances, corporate standard operating procedures, policies, rules and regulations.
Key Responsibilities:
- Responsible for the Controlled Substances Stability Laboratory Program at the Titusville and Raritan sites.
- Responsible for keeping up to date on FDA/GMP/DEA regulations.
- Contact DEA/State of NJ Controlled Substance Authority, as required, to request on-site visits to assess changes in the facility/processes that impact controlled substances.
- Responsible for timely issuance and submittal of controlled substances reports/documents to the federal and state regulatory agencies and to corporate group.
- Responsible for review, evaluation and approval of SOP's and Change Controls related to controlled substances.
- Maintains all necessary licenses up to date e.g. DEA and State of New Jersey Controlled Substance Authority.
- Support the Internal Audit Program to assure site compliance with current GMP's guidelines, controlled substances, corporate standard operating procedures, policies, rules, and regulations.
- Has thorough understanding of process criteria and regulations and business impact of decisions and actions
- Support the internal/external Corporate and/or Regulatory Agencies audits/inspections. Perform audit readiness and audit support role.
- Execute the inspection readiness plan and report issues, risk, progress to the CS Leadership Team. Perform audit readiness and audit support role.
- Acts as a compliance representative with site-controlled substance project teams and New Product activities specially related to controlled substances.
- Provide regulatory/Compliance guidance and leadership to support all company processes.
- Monitors trends, identifies issues, recommends, and implements appropriate actions.
- Complies with the goals of the quality team and with overall business and process goals, principles of conduct expressed in our Company Credo and policies and Safety and Environmental procedures in all areas.
- Support the CS Leadership as requested, including internal & external interactions.
- Manage the Export Tool, SAP, eLIMS and version changes and tool maintenance. This will include the impact evaluation of procedures impacted and accurate communication changes.
Education:
- A Minimum of bachelor's degree required; master's is helpful.
Required:
- A minimum of five (5) years proven experience.
- Literacy in SAP System in the inventory. This includes the understanding of relevant transactions in the laboratory, quality assurance, compliance, and financial areas.
- Technical writing, problem solving, decision making, leadership, high level judgment and discernment skills, business and technical acumen, ability to facilitate and inspire change required.
- Computer knowledge in Microsoft Software application is required (Word, Excel, Power Point, Outlook).
- Demonstrates knowledge of GMP's, Compliance, internal and external regulations, Policies and procedures are required; as well as broader knowledge of all processes within the Quality area preferred.
- Experience in the Compliance areas (Complaints, Internal Audits, Change Controls) within the pharmaceutical industry preferred.
- Knowledge in Controlled Substance remediation processes, DEA & Department of Justice legal agreements, COMET system, CS Metrics & Export Tools, ARCOS System, and SAP System applications are strongly preferred.
- Must have the ability to take initiative and work independently where appropriate, effectively manage timelines, prioritize files under regulatory scrutiny, and work independently.
- Must be an analytical and strategic thinker with the ability to build coordinated sector wide solutions to align with sector and enterprise requirements.
- This position is anticipated to have up to 15% travel. Time is expected to be split between Raritan NJ and Titusville NJ at a 50% ratio. Travel is minimal to support other internal and external CS stakeholders and attend conferences/workshops as needed.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
The anticipated base pay range for this position is :
$91,000-$147,200
Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be 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. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits 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.