Quality Control Specialist (Incoming Quality Control)

• 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.
• 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.
• Executes routine and non-routine analysis, may include, but not limited, to cGMP release, verification testing using various compendia, analytical techniques such as pH, Osmolality, Conductivity, TOC, Karl Fischer, and compendial wet chemistry.
• 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.
• Support department risk assessments and participates in audit walk-throughs.
• Supports training of departmental personnel in appropriate technique and related topics.
• 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.
• Oversees special projects on analytical and instrument problem solving. May develop testing and analysis methods and procedures in accordance with established guidelines.
• Supports Quality Control department at QMR by preparing slide deck and presenting laboratory metrics.
• Authors new/revise Standard Operating Procedures, Specifications, Protocols / Summary Reports /Analytical Master Plans for QC
• Compiles data for documentation of test procedures that may include stability program testing and formulation studies.
• Champion’s continuous improvement projects to maximize laboratory efficiencies and to strengthen compliance.
• Other related job duties as assigned.

• Possess a strong understanding of compendia and QC testing techniques.
• Full understanding of area of specialization; resolves a wide range of issues in creative ways.
• Networks with senior internal and external personnel in own area of expertise.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• An understanding of FDA/EMEA regulations.
• Proficient in Microsoft Word, Excel, Power Point and other applications.
• Ability to receive little instruction on day-to-day work, general instructions on new assignments.
• Excellent interpersonal, verbal and written communication skills with strong technical writing experience.
• Extensive knowledge of GLP and GDocP principles.
• Bachelor's degree in scientific disciplines such as Chemistry, Biochemistry, Biology, Microbiology or related field with 5 years’ experience in GMP environment.

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. The level of this position will be based on the final candidate’s qualifications.

236 million lives were touched by Novartis medicines in 2022, 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.

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.

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 [email protected] 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.

The pay range for this position at commencement of employment is expected to be between $40.38 / hour to $60.57/ hour ; 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.