Senior Analyst Quality Control

at  Johnson Johnson

Janssen Supply Chain Quality Control, US Stability Operations is recruiting for a Senior Analyst Quality Control! This position will be located in Raritan, 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 Analyst QC manages and executes day-to-day Quality Control sample management activities for the NJ Stability laboratory, ensuring GMP compliance and accuracy and timeliness of specified stability processes. The Senior Analyst QC carries out duties in compliance with all local, state, federal and international regulations and guidelines (including FDA, EPA, OSHA, DEA, etc.) as well as all company and site policies and procedures.
The Senior Analyst QC is accountable to manage and assure quality & compliance for all activities and ensure all regulatory commitments are met, including compliance to stability pull windows. They will represent stability operations as an SME for issues that arise in the area of Sample Management.

Key Responsibilities:

• Responsible for the daily pulling (physically and electronically) of samples in the stability chambers. · Provide samples to the stability laboratory making sure all samples are pulled within compliance.
• Responsible for handling controlled substances in compliance with all applicable DEA regulations from arrival to final disposal.
• Responsible for managing the accurate receipt and storage of incoming sample shipments to the site, as well as the accurate shipping of samples to various other labs/sites
• Ensure all annual stability commitments are verified & labeled upon receipt into the Stability Monitoring Program and all monthly pulls are performed on time to meet regulatory commitments
• Conducts inventory check of all samples and reference standards
• Coordinate the acquisition, transportation, receipt, and storage of stability samples and associated reference standards from a global network of manufacturing facilities
• Maintain stability chambers to ICH guidelines and is act as the first line notification for the Environmental Monitoring System. Diligently respond 24/7 to chamber excursions and advise team members on system status
• Document chamber maintenance, repairs and excursions in logbooks.
• Interact with the manufacturing and packaging sites to ensure awareness of current stability policies and commitments, and to procure the necessary batches for the program
• Update protocols, studies and samples as needed in LIMS database
• Initiate, write and review technical documents including investigations, SOP’s, protocol, reports, CAPA’s, etc. associated with the duties of this position
• Support Health Authority inspections as Sample Management SME

QUALIFICATIONS

Education:

• Bachelors Degree or equivalent experience required; preferably in the science field

Experience and Skills:

Required:

• 4-6 years prior experience in stability program management
• Ability to work with and lead others in a team environment. Strong interpersonal and written/oral communication skills
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems
• Ability to quickly process complex information and often make critical decisions with limited information
• Ability to prioritize multiple projects daily while being flexible and adaptable to frequently shifting priorities
• Detailed knowledge of Johnson & Johnson Quality and Compliance standards
• Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)

Preferred:

• Preferred experience in a regulated quality environment, specifically within stability operations
• Creativity regarding basic problem solving and troubleshooting in laboratory tasks
• Should have the capability to develop improvement ideas and independently implement associated solutions.
• Be able to positively influence peers, key stakeholders and management
• Positive and optimistic with the ability to act as a pro-active change agent

Other:

• Up to 10% domestic travel may be required, with frequent travel between Titusville and Raritan sites
• The anticipated base pay range for this position is $76,000 to $121,900

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)).
• This position is eligible to participate in the Company’s long-term incentive program.
• 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. https://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
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
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.

• Responsible for the daily pulling (physically and electronically) of samples in the stability chambers. · Provide samples to the stability laboratory making sure all samples are pulled within compliance.
• Responsible for handling controlled substances in compliance with all applicable DEA regulations from arrival to final disposal.
• Responsible for managing the accurate receipt and storage of incoming sample shipments to the site, as well as the accurate shipping of samples to various other labs/sites
• Ensure all annual stability commitments are verified & labeled upon receipt into the Stability Monitoring Program and all monthly pulls are performed on time to meet regulatory commitments
• Conducts inventory check of all samples and reference standards
• Coordinate the acquisition, transportation, receipt, and storage of stability samples and associated reference standards from a global network of manufacturing facilities
• Maintain stability chambers to ICH guidelines and is act as the first line notification for the Environmental Monitoring System. Diligently respond 24/7 to chamber excursions and advise team members on system status
• Document chamber maintenance, repairs and excursions in logbooks.
• Interact with the manufacturing and packaging sites to ensure awareness of current stability policies and commitments, and to procure the necessary batches for the program
• Update protocols, studies and samples as needed in LIMS database
• Initiate, write and review technical documents including investigations, SOP’s, protocol, reports, CAPA’s, etc. associated with the duties of this position
• Support Health Authority inspections as Sample Management SM