Job Description Summary
The Senior Coordinator, Quality Control Sample, Quality Control Sample, leads sample control support at the assigned site/laboratory.
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 Stability sets and pulls including aliquoting and shipping during the study.
Other related job duties as assigned.
Essential Requirements:
High School degree with 6 years related experience in a GMP Quality Control Laboratory or Associate’s degree with 4 years related experience in a GMP Quality Control Laboratory OR
Preferred, Bachelors’ degree in a relevant scientific concentration plus 2 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 $66,800 and $124,000/year. 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