Associate Coordinator Quality Control Mgmt job opportunity at Novartis.

Home Jobs In United States Of America Tag: Job Associate Coordinator Quality Control Mgmt position at Novartis


DateMore Than 30 Days Ago bot
Novartis Associate Coordinator Quality Control Mgmt
Experience: 8-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeAssociate
loacation Durham, United States Of America
loacation Durham....United States Of America

Job Description Summary The Associate Coordinator, Quality Control Sample, leads sample control support at the assigned site/laboratory. Location: Durham, NC #LI-Onsite This role is located on-site in Durham, NC. Novartis is unable to offer relocation support for this role; please only apply if this location is accessible for you.   Job Description Key Responsibilities : Oversight of QC in-process, release, raw material, and stability, and development samples, associated document management, and collection of data. Adherence to all GMP requirements, a proficiency in understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, personal development, and support of investigations and inspections/audits. Manage sample tracking and the inventory system to track commercial and development samples. Generate sample submission forms for various testing facilities and process returned results. Collect sample forecasts to ensure lead time notice. Confirm testing was complete when sample invoices arrive. Follow/track international shipments, and alert logistics group of any customs clearance issues. Inspect incoming sample shipments and take necessary actions if samples do not comply with SOPs. Review and evaluate temperature data reports from temperature monitoring devices included with sample shipments. Execute protocols to support network stability, qualified material programs and pipeline product studies. Create and continuously improve sample management procedures and processes. Communicate with other departments and sites including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs. Write and revise documents such as SOPs and technical reports. May support the Manager for activities related to training of employees, coordination of tasks, compliance with GMP, and identifying and implementing corrective and preventive actions. Support for third party testing laboratories and manage testing turnaround times for testing metrics. Support new implementations of LIMs programs including updates and LIMs activities. Create/maintain change controls to ensure compliance with regulatory requirements and company/polices. Act as subject matter expert for sample management procedures. Author and review protocols, reports, investigations, non-conformance, CAPAs, and other records related to Quality control. Support Stability sets and pulls including aliquoting and shipping during the study. Requirements: High School degree with 8 years related experience in a GMP Quality Control Laboratory or Associate’s degree with 6 years related experience in a GMP Quality Control Laboratory OR Preferred, Bachelors’ degree plus 4 years related experience in a GMP Quality Control Laboratory. Possess a strong understanding of the requirements of sample receipt and inventory management in a GMP laboratory. Excellent oral and written communication skills with strong technical writing experience required. Able to work independently and effectively within the group, within Quality, and across the site. Ability to work in both paper based and electronic laboratory information management systems. The salary for this position is expected to range between $32.10 and $59.61/hour. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.   EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.    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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or 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.   Salary Range $66,780.00 - $124,020.00   Skills Desired Agility, Audit Management, Business Partnering, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Quality Management, Risk Management, Root Cause Analysis (RCA), Self-Awareness, Sop (Standard Operating Procedure), Technological Expertise

Other Ai Matches

Medical Scientific Liaison (CRM) Applicants are expected to have a solid experience in handling Job related tasks
Process Technician - Supply Management Applicants are expected to have a solid experience in handling Job related tasks
BUSINESS INSIGHT & STRATEGY ANALYST H/F EN STAGE Applicants are expected to have a solid experience in handling Job related tasks
Head Site QA Operations/Assoc Dir Applicants are expected to have a solid experience in handling Job related tasks
Associate Director - GenAI - Power Platform Applicants are expected to have a solid experience in handling Job related tasks
Senior Lead or Lead, Public Affairs Applicants are expected to have a solid experience in handling Public Affairs related tasks
Director, Strategy & Operations to Global Head Medical Affairs Applicants are expected to have a solid experience in handling Strategy & Operations to Global Head Medical Affairs related tasks
Associate Director Pipeline Operations Applicants are expected to have a solid experience in handling Job related tasks
Tehnik v proizvodnji farmacevtskih učinkovin (m/ž/d) Applicants are expected to have a solid experience in handling Job related tasks
Manager, Advanced Analytics Applicants are expected to have a solid experience in handling Advanced Analytics related tasks
Cardiovascular Territory Account Specialist –New Haven, CT Applicants are expected to have a solid experience in handling CT related tasks
Manager - International BPA Applicants are expected to have a solid experience in handling Job related tasks
Lehre Elektrotechnik (m/f/d) Applicants are expected to have a solid experience in handling Job related tasks
Radioligand Therapies (RLT) Director, Ecosystem Lead - Tri - State Applicants are expected to have a solid experience in handling Ecosystem Lead - Tri - State related tasks
Senior Supply Chain Manager Applicants are expected to have a solid experience in handling Job related tasks
S. Manager - AI & Innovation Applicants are expected to have a solid experience in handling Job related tasks
Global Regulatory Affairs Associate Director (Cardio-Metabolic) Applicants are expected to have a solid experience in handling Job related tasks
Üretim Operatörü - Kurtköy, Istanbul Applicants are expected to have a solid experience in handling Istanbul related tasks
Skrbnik uvajanja sprememb v proizvodnjo (m/ž/d) / Production Change Manager (m/f/d) Applicants are expected to have a solid experience in handling Job related tasks
Assoc. Dir. DDIT ISC Threat Hunting Applicants are expected to have a solid experience in handling Job related tasks
Senior Business Analyst Applicants are expected to have a solid experience in handling Job related tasks
Data Steward Expert (with language proficiency in Mandarin/Thai/ Vietnamese/Japanese/Arabic/Korean) Applicants are expected to have a solid experience in handling Job related tasks
Commercial Excellence Manager Applicants are expected to have a solid experience in handling Job related tasks