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Manager, Quality Control Operations

Company

Novartis

Address , Millburn, Nj
Employment type FULL_TIME
Salary
Expires 2023-06-24
Posted at 1 year ago
Job Description

The Quality Control Operations Manager will be responsible for insuring that day-to-day QC laboratory operation is performed in a manner that is compliant with GMP/FDA regulations, AAA and Novartis standard operating procedures. Due to the nature of the process (radioactive) this role requires basic proficiency, ownership of the quality control techniques, and understanding of radiation safety standards.
Main responsibilities:
  • Writes, reviews, and approves documents needed for laboratory operation, such as Standard Operating Procedures (SOP’s), methods, specifications, change control requests, method and equipment validation activities, etc.
  • Supports their team for all technical aspects related to quality control testing readiness, including Quality Control (QC) reagents and materials management, equipment preparation and daily cleaning and maintenance activities, sample management, and QC testing.
  • Oversees day-to-day operation of Quality Control laboratory and develop the skills of their team for career growth, keeps up with industry trends and best practices and drives spirit of continuous improvement to ensure Inspection readiness state.
  • Acts as Subject Matter Expert in his or her area of expertise: primary contact for troubleshooting, deviation/OOS investigations, assesses product and environmental data and performs trending, and QC documentation management.
  • Selects, trains, supports laboratory personnel in the performance of the testing procedures required to meet regulatory and scientific standards for pharmaceutical products.
  • Manages Quality Control Key Performance indicators (KPIs) (timeliness, training, testing cycle time, periodic review, etc.), oversees stability testing program at Millburn facility and collaborates with Global organization to resolve any analytical testing problems, recommend appropriate changes, if required.
  • Acts as designee and make key decisions regarding quality control processes in the absence of the QC Head, facilitates a culture of “speaking up”, ensures all compliance activities are followed and supports regulatory inspections and audits.
  • Ensures quality control events are categorized and escalated timely and conducts or delegate laboratory investigations, including OOS/OOT/OOEs and deviations. Ownership and/or oversights of laboratory based corrective and preventive actions (CAPA) implementation.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum requirements

  • Bachelor’s degree in relevant Analytical testing/Microbiology discipline.
Minimum of 5-7 year experience in Quality Control in Good Manufacturing Practice (cGMP) or aseptic environment required.
  • Good Knowledge of cGMP regulations and FDA guidance applicable to Quality

Why Novartis?
236 million lives were touched by Novartis medicines in 2022, and while we’re
Strategic Talent MarketingBusiness Use Onlyproud 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 achievehere at Novartis!
Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.Join our Novartis Network:If this role is not suitable to your experience or career goals but you wish to stay connected to hearmore 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

No

Early Talent

No