Exp Anlst Quality Assurance

Raritan, NJ - USA

Monthly Salary: $ 79000 - 127650

Posted on: 17 hours ago

Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Raritan New Jersey United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at are searching for the best talent for a Quality Assurance Batch Release Specialist II to join our Team! This is an onsite/hybrid role.

Purpose

The Quality Assurance Batch Release Specialist II is an exempt level position with responsibilities for providing quality attributes over a wide range of activities and projects in the CAR-T facility to support clinical and commercial efforts to release material for human use.

Responsibilities

Responsible for disposition of final drug product.
Review released documentation for all manufacturing activities executed in accordance with Good Documentation Practices (GDP).
Work in a team based cross-functional environment to complete tasks required to meet business objectives.
Author and review release documentation.
Collaborate with (cross) functional departments to resolve issues related to batch review/release investigations and receipt of QC test results to allow for timely release of final product batches according to department and business plan in a complex fast paced supply chain organization.
Perform duties/tasks under minimal supervision according to standard operating and manufacturing procedures and demonstrate ability to attain resources and information from established internal contacts.
Consistently perform tasks in adherence with safety policies quality systems and cGMP requirements as well as according to state and federal regulatory requirements.
Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
Ensure readiness of records for regulatory inspections and internal audits.

Qualifications/Requirements

Minimum of a Bachelors degree in Science Engineering or equivalent technical field is required
Minimum of 2 years of relevant experience within Manufacturing Quality Assurance or Batch Release in either the pharmaceutical or biotech industries

Skills/Experience:

Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) regulations and FDA/EU guidelines
Highly organized with proven attention to detail and ability to follow procedures with minimal supervision. Knowledge of cGMP/GTP regulations and FDA
Strong social skills willingness to take initiative and capability of working in a collaborative team environment.
Proficient verbal communication skills with the ability to effectively summarize and present results
Ability and flexibility to work 10-hr shifts between the operational hours of 8am-7pm and weekends or other shifts 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 & 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.

Required Skills:

Preferred Skills:

Business Alignment Business Behavior Coaching Compliance Management Continuous Improvement Data Analysis Detail-Oriented Goal Attainment Human-Centered Design Internal Controls Issue Escalation Problem Solving Process Oriented Quality Control (QC) Quality Management Systems (QMS) Quality Standards

The anticipated base pay range for this position is :

$79000.00 - $127650.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys long-term incentive program.

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 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: -