Novartis
Quality Control Specialist
The Specialist, Quality Control, assists and supports the organization with compliance and ongoing preparation, testing and monitoring of conformance to established quality processes and standards for manufacturing and production. Location: Durham, NC Shift: 2nd 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:
Bachelor's 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 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. 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 email to us.reasonableaccommodations@novartis.com or 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 Specialist, Quality Control, assists and supports the organization with compliance and ongoing preparation, testing and monitoring of conformance to established quality processes and standards for manufacturing and production. Location: Durham, NC Shift: 2nd 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:
Bachelor's 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 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. 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 email to us.reasonableaccommodations@novartis.com or 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.