Résumé
About the Role
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.
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
•Bachelors’ degree (preferred) 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 pay range for this position at commencement of employment is expected to be between $27.40 and $41.15 hourly; 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.
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.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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