Specialist, Quality Control

• 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.
• Support department risk assessments and participates in audit walk-throughs.
• Conducts routine and non-routine analysis, including but not limited to biochemical and chemical analysis, of raw materials, in-process items and finished product according to established operating procedures.
• Compiles data for documentation of test procedures that may include stability program testing and formulation studies.
• Supports Quality Control department at QMR by preparing slide deck and presenting laboratory metrics.
• 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.
• Oversees special projects on analytical and instrument problem solving. May develop testing and analysis methods and procedures in accordance with established guidelines.
• Supports training of departmental personnel in appropriate technique and related topics.
• Champion’s continuous improvement projects to maximize laboratory efficiencies and to strengthen compliance.
• Other related job duties as assigned.

• Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 5 years’ experience in GMP environment.
• Full understanding of area of specialization; resolves a wide range of issues in creative ways.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• 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.
• Proficient in Microsoft Word, Excel, Power Point and other applications.
• Extensive knowledge of GLP and GDocP principles.
• An understanding of FDA/EMEA regulations.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Additionally, 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.