Address
Form of work
Salary394804BR
Specialist, Quality Control
USA
About the role
The Specialist, Quality Control, assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality processes and standards for manufacturing and production.
- Executes routine and non-routine analysis, may include, but not limited, to cGMP release and characterization testing using analytical techniques such as potency, PCR (ddPCR, qPCR), Immunoassays (ELISA), chromatography (HPLC-UV, HPLC- ELSD, HPLC-MS), spectrophotometry, AUC, and electrophoresis (CE, PAGE, western blotting).
- Assists in the evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
- Reviews data obtained for compliance to specifications and reports abnormalities. Performs trend analysis of methods / environmental data / assay controls & standards and draws conclusions.
- Capable of delivering to assigned work schedule with attention to detail and accuracy.
- Compiles data for documentation of test procedures that may include stability program testing and formulation studies.
- Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT/OOE and Investigation.
- Authors new/revise Standard Operating Procedures, Protocols / Summary Reports /Analytical Master Plans for QC.
- Supports training of departmental personnel in appropriate technique and related topics.
EEO Statement
We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
- Novartis: e-mail us.reasonableaccommodations@novartis.com or call +1 (877)395-2339
- Sandoz: e-mail reasonable.accommodations@sandoz.com or call: +1-609-422-4098
Role Requirements
- Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 5 years of experience in pharmaceutical industry or equivalent or 4 years of experience at GTx.
- Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
- Ability to receive little instruction on day-to-day work, general instructions on new assignments.
- Networks with senior internal and external personnel in own area of expertise.
- Excellent interpersonal, verbal and written communication skills with strong technical writing experience.
- Possess a strong understanding of QC testing technique.
- Extensive knowledge of GLP and GDocP principles.
- An understanding of FDA/EMEA regulations.
The pay range for this position at commencement of employment is expected to be between $84,000 and $126,000 annual; 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.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
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.
Division
Operations
Business Unit
QUALITY
Work Location
Durham, NC
Company/Legal Entity
Novartis Gene Therapies
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
