Novartis Hiring for Quality Assurance Associate Hours: Sun-Wed pm-pm ( -hour days) job in Morris Plains Full Time

About the role
Location: On-site Morris Plains, NJ

Hours: Sun-Wed 1:00pm-11:00pm. (4 10-hour days)

Number of openings: 2

The Quality Operations Associate is responsible for first level, hands on, day-to-day cGMP facilitator role for all site related GMP activities. They interact directly with site staff, who are performing the daily operational functions in support of their effort to produce quality products. This role ensures that the quality strategy is implemented and that there is a continuous drive to improve product and process quality within the PU

Major Accountabilities:

This position will be expected to work a 4 day/10 hr work shift. (Sunday through Wednesday or Wednesday through Saturday, some evenings may be required)
• Under the guidance of the Quality Operations Process Manager/Team Manager, provides oversight to operations on the shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise.
• Review and audit production batch records to ensure adherence to Novartis policies, SOPs, and cGMP requirements.
• Conduct routine shop floor tasks related to aseptic operations including but not limited to ViMOS, APV program observations, walkthrough program, QA area release, etc.
• Interface closely with PU to assist with batch record review, release and compliance issues.
• Under the guidance of the Quality Operations Process Manager/team manager, perform triaging of events, initiate deviation reports in the appropriate quality system and partner PU and other areas for issue resolution.
• Actively participate in process improvement initiatives aiming for Right First Time (RFT) on documentation and deviation reduction.
• Ensures adequate levels of documentation are adequate and compliant to existing procedures
• Review and approval of track and trend and minor deviation investigations and assist in CAPA plan establishment in accordance with applicable SOPs.
• Participates in activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings
• Implements and ensures adherence of appropriate regulations and Novartis quality standards.
• Write, review and approve Standard Operating Procedures (SOPs), as needed
• Assist QA Experts, Process Manager, and Team Management in providing documentation as needed for self-inspections and external audits.
• Assist in audit preparation for shop floor tours as needed
• Champion a Quality Culture and ensure a safe working environment.
• Complete job-related training as required
• Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.
• Demonstrates and role models the Novartis values and behaviors
Commitment to Diversity & Inclusion:
We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

• Novartis: e-mail [email protected] or call +1 (877)395-2339
• Sandoz: e-mail [email protected] or call: +1-609-422-4098

Role Requirements
Education:

BA degree in Biological Sciences or equivalent relevant career experience may be accepted.

Experience:

• A minimum of 2 years of experience in a Pharmaceuticals environment.
• Knowledge and understanding of cGMPs, keeping up to date with current industry
issues and changing regulations.

Specific Professional Competencies:

• Excellent oral and written communication skills required.
• Demonstrate leadership ability and excellent interpersonal skills.
• Ability to work under direction of senior team members, independently, and as part of a team if necessary. Strives for simplicity and clarity.
• SAP, Trackwise, MES, LIMS knowledge preferred
• Experience in Deviation Management and batch disposition preferred