Analyst Quality Assurance

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Job Function : Quality

Job Sub Function : Quality Assurance

Job Category : Professional

All Job Posting Locations :

Titusville, New Jersey, United States of America

Job Description :

Johnson & Johnson is currently recruiting for an Analyst Quality Assurance! This position will be located in Titusville, NJ.

Position Summary

Quality Assurance supports stability site efforts to remain compliant with corporate and regulatory requirements. They are responsible for ensuring the Janssen US Stability sites maintain a state of inspection readiness through audits and by assuring compliance with regulatory and J&J requirements.

Quality Assurance maintains a high level of quality knowledge with understanding of the quality and technical content of reports, investigations, and corrective and preventative actions that are documented by the group.

Tasks / Duties / Responsibilities

Quality & Compliance :

Maintains inspection readiness system and activities for the site

Participates in quality audits, inspection activities and responses

Draft, edit, review and approve department standard operating procedures (SOPs) and work instructions (WIs)

Successfully completes regulatory and job training requirements

Provides training for Quality concepts or systems

Responsible for assuring compliance to all relevant regulatory requirements (e.g., global cGMPs, DEA, EH&S) is monitored and gaps are mitigated

Coordinates, maintains, tracks, monitors, reports and drives quality metrics

Monitors non-conformance and commitment data for trends

Assembles information (i.e., builds charts, graphs, etc.), participates in Site Management Reviews (SMR) and tracks action items to closure

Escalates issues to management in timely manner and works with management to address and remediate issues

May approve (or develop) cGMP training materials / plans for functional areas within site Stability Operations

May participate in quality issues / investigations as an SME or perform Quality review and approval of records

Projects / Meetings

Participates in any and all required meetings related to quality

Support Site Management Review (SMR)

Participate in Lean initiatives, as applicable, and assist in driving Quality, Compliance and Lean thinking throughout Stability Operations

May participate in continuous improvement activities including assessing current processes, providing improvement input and working with partners to implement changes.

Qualifications : Education :

A minimum of a Bachelors or equivalent University degree is required, with a focus in science or related field preferred.

Required Knowledge, Skills and Abilities :

A minimum of 2-4 years relevant working experience

Knowledge and understanding of current Good Manufacturing Practices (cGMP)

Basic knowledge of analytical technologies used in a Quality Control Stability Laboratory

Basic Knowledge of global regulatory and compendial (USP, EP, JP, etc.) requirements

Ability to participate and lead an individual project with minimal guidance from supervision / management in the training and document management space.

Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)

May occasionally assist the supervisor in establishing priorities

Ability to influence others successfully

Proficient with Quality Systems for training and document management (e.g., Trackwise, ComplianceWire, SUMMIT, TruVault)

Ability to write and / or effectively review documents for Good Document Practices (GDP)

Preferred Knowledge, Skills and Abilities :

Possesses the capability to develop process improvement ideas and work within a team to implement associated solutions

Possesses the ability to positively influence peers

Positive and optimistic with the ability to act as a pro-active change agent

Other :

The expected base pay for this position is 69,500-102,350 USD$

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 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 Condolence Leave – 30 days for an immediate family member :

5 days for an extended family member Caregiver Leave –

10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below.

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 .]

Johnson & 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, external applicants please contact us via . internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$69,500-$102,350  USD$

Additional Description for Pay Transparency :

• 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 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 Condolence Leave – 30 days for an immediate family member : 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below.