Quality Control Analyst

Full Time
Millburn, NJ
Posted
Job description

AAA Statement

Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear medicine.
AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).

Job Description

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
The Quality Control (QC) Analyst will perform daily quality control testing as well as setup and preparation of instruments and equipment associated with the testing.

Your responsibilities include, but are not limited to:

  • Prepares all materials while maintaining material identity as defined by procedure.
  • Performs relevant QC testing, such as high-performance liquid chromatography, instant thin layer chromatography, endotoxin testing, sterility testing, growth promotion, Environmental Monitoring, and radiochemical purity testing defined by procedure and qualification requirements (if applicable).
  • Documents results within electronic and paper-based systems as applicable.
  • Follows cGMP, GLP, and GDP quality policies and procedures. Reviews QC documents to ensure completeness, accuracy, consistency and clarity.
  • Prepares and qualifies equipment for use on a daily basis by executing system suitability testing and daily checks to ensure that equipment is fit for purpose.
  • Performs calibration checks to ensure within calibration and preventative maintenance tasks for equipment.
  • Performs investigations such as deviations, OOS, OOE, OOT and assists with determining effective CAPA actions as applicable.
  • Revise SOPs, forms, laboratory test records as required.
  • Maintains operator qualification records and ensures qualification is current.
  • Completes applicable documents and records such as testing records using good documentation practices.
  • Collaborates with rest of facility team, as well as AAA corporate functions and other facilities.
  • Supports continuous improvement efforts such as Lean Labs and applicable projects.

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com.

https://www.youtube.com/watch?v=ggbnzRY9z8w

EEO Statement

The Novartis Group of Companies 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.

Minimum requirements

What you’ll bring to the role:

HS Diploma or equivalent required; Bachelor’s degree in a scientific or health related field strongly preferred

  • 3 years of experience in the pharmaceutical, microbiology, sterile manufacture, or medical device industry, ideally in a QC laboratory setting.
  • Previous experience with GxP concepts preferred.
  • Experience using Quality Systems such as Chromelian, LIMS, ESOP, Trackwise, 1QEM, and/or ENNOV preferred .

Why Advanced Accelerator Applications (AAA)?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. 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:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

The pay range for this position at commencement of employment is expected to be between $84,000 and $126,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Division

ONCOLOGY

Business Unit

ADVANCED ACCELERATOR APPLICATIONS

Country

USA

Work Location

Millburn, NJ

Company/Legal Entity

AAA USA Inc.

Functional Area

Quality

Job Type

Full Time

Employment Type

Regular

Shift Work

Yes

Early Talent

Yes

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