QC Specialist

Job Description Summary

Job Description

Key Responsibilities:

• Executes routine and non-routine analysis for cGMP release and characterization testing using techniques including but not limited to ddPCR ELISAs NGS Western Blot and Bioburden.
• 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.
• 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.
• Other related job duties as assigned.

Essential Requirements:

• Bachelors degree in scientific disciplines such as Biochemistry Biology Microbiology or related field with 5 years experience in GMP environment or 4 years at GTx
• Excellent interpersonal verbal and written communication skills with strong technical writing experience required. Previous investigation experience a plus.
• Proven ability to work effectively in a team environment. Collaborates cross functionally with other departments to achieve site goals.
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Exercises judgment within defined procedures and practices to determine appropriate action including critically thinking troubleshooting and problem-solving skills.
• Normally receives general instructions on routine work detailed instructions on new projects or assignments.
• Self-motivated detail-oriented and willing to accept temporary responsibilities outside of core duties.

The salary for this position is expected to range between $37.02/hr and $68.75/hr.

The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other benefits. In addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion sex national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected 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 to perform the essential functions of a position please send an e-mail to or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired