Senior Analyst, (Development) Quality Control Sample Management and Stability
Imagine… 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapy are laser focused on bringing hope and possibility to those devastated by rare genetic diseases. We use cutting-edge technology to turn promising gene therapies into proven treatments beginning with SMA but also focusing on Rett Syndrome and Friedreich's Ataxia. Imagine the lives you could transform by joining the Novartis Gene Therapy team.
The Senior Analyst, Quality Control Sample Management and Stability, leads sample control support at the assigned site/Laboratory.
- Coordination of QC in-process, release, and stability 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.
- Sample tracking and management of the inventory system to track development samples.
- Manages inventory and ordering of laboratory consumables.
- Generates sample submission forms for various testing facilities.
- Collects sample forecasts to ensure lead time notice.
- Confirms testing was complete when sample invoices arrive.
- Follows/tracks international shipments, and alert logistics group of any customs clearance issues.
- Inspects incoming sample shipments and take necessary actions if samples do not comply with SOPs.
- Reviews and evaluates temperature data reports from temperature monitoring devices included with sample shipments.
- Creates equipment, inventory, and sample receipt and tracking logbooks.
- Creates and approves sample management procedures.
- Communicates with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs.
- Writes and revises documents such as SOPs, stability protocols and technical reports.
- May support stability study execution (stability time point pulls, aliquoting).
- May support the Manager for activities related to training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions.
- Other related job duties as assigned.
- Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 2 years' experience in GMP environment.
- 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.
The level of this position will be based on the final candidate's qualifications.
769 million lives were touched by Novartis medicines in 2020, 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!
Novartis Gene Therapies Benefit Summary:
Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-MG1
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